Pixel array medical systems, devices and methods

ABSTRACT

Systems, instruments, methods, and compositions are described involving removing a portion of the epidermis within a donor site on a subject, and harvesting dermal plugs within the donor site. An injectable filler is formed by mincing the dermal plugs. The injectable filler is configured for injecting into a recipient site on the subject.

RELATED APPLICATIONS

This application claims the benefit of U.S. patent application No.62/331,076, filed May 3, 2016.

This application claims the benefit of U.S. Patent Application No.62/456,775, filed Feb. 9, 2017.

This application claims the benefit of U.S. Patent Application No.62/481,391, filed Apr. 4, 2017.

This application is a continuation in part of U.S. patent applicationSer. No. 15/431,247, filed Feb. 13, 2017.

This application is a continuation in part of U.S. patent applicationSer. No. 15/431,230, filed Feb. 13, 2017.

This application is a continuation in part of U.S. patent applicationSer. No. 15/017,007, filed Feb. 5, 2016.

This application is a continuation in part of U.S. patent applicationSer. No. 15/016,954, filed Feb. 5, 2016.

This application is a continuation in part of U.S. patent applicationSer. No. 14/840,307, filed Aug. 31, 2015.

This application is a continuation in part of U.S. patent applicationSer. No. 14/840,290, filed Aug. 31, 2015.

This application is a continuation in part of U.S. patent applicationSer. No. 14/840,267, filed Aug. 31, 2015.

This application is a continuation in part of U.S. patent applicationSer. No. 14/840,284, filed Aug. 31, 2015.

This application is a continuation in part of U.S. patent applicationSer. No. 14/840,274, filed Aug. 31, 2015.

This application is a continuation in part of U.S. patent applicationSer. No. 14/505,183, filed Oct. 2, 2014.

This application is a continuation in part of U.S. patent applicationSer. No. 14/505,090, filed Oct. 2, 2014.

This application is a continuation in part of U.S. patent applicationSer. No. 14/099,380, filed Dec. 6, 2013.

This application is a continuation in part of U.S. patent applicationSer. No. 14/556,648, filed Dec. 1, 2014, which is a continuation of U.S.patent application Ser. No. 12/972,013, filed Dec. 17, 2010, now U.S.Pat. No. 8,900,181.

TECHNICAL FIELD

The embodiments herein relate to medical systems, instruments ordevices, and methods and, more particularly, to medical instrumentationand methods applied to the surgical management of burns, skin defects,and hair transplantation.

BACKGROUND

The aging process is most visibly depicted by the development ofdependent skin laxity. This life long process may become evident asearly as the third decade of life and will progressively worsen oversubsequent decades. Histological research has shown that dependantstretching or age related laxity of the skin is due in part toprogressive dermal atrophy associated with a reduction of skin tensilestrength. When combined with the downward force of gravity, age relateddermal atrophy will result in the two dimensional expansion of the skinenvelope. The clinical manifestation of this physical-histologicalprocess is redundant skin laxity. The most affected areas are the headand neck, upper arms, thighs, breasts, lower abdomen and knee regions.The most visible of all areas are the head and neck. In this region,prominent “turkey gobbler” laxity of neck and “jowls” of the lower faceare due to an unaesthetic dependency of skin in these areas.

Plastic surgery procedures have been developed to resect the redundantlax skin. These procedures must employ long incisions that are typicallyhidden around anatomical boundaries such as the ear and scalp for afacelift and the inframammary fold for a breast uplift (mastopexy).However, some areas of skin laxity resection are a poor tradeoff betweenthe aesthetic enhancement of tighter skin and the visibility of thesurgical incision. For this reason, skin redundancies of the upper arm,suprapatellar knees, thighs and buttocks are not routinely resected dueto the visibility of the surgical scar.

The frequency and negative societal impact of this aesthetic deformityhas prompted the development of the “Face Lift” surgical procedure.Other related plastic surgical procedures in different regions are theAbdominoplasty (Abdomen), the Mastopexy (Breasts), and the Brachioplasty(Upper Arms). Inherent adverse features of these surgical procedures arepost-operative pain, scarring and the risk of surgical complications.Even though the aesthetic enhancement of these procedures is anacceptable tradeoff to the significant surgical incisions required,extensive permanent scarring is always an incumbent part of theseprocedures. For this reason, plastic surgeons design these procedures tohide the extensive scarring around anatomical borders such as thehairline (Facelift), the inframmary fold (Mastopexy), and the inguinalcrease (Abdominoplasty). However, many of these incisions are hiddendistant to the region of skin laxity, thereby limiting theireffectiveness. Other skin laxity regions such as the Suprapatellar(upper-front) knee are not amendable to plastic surgical resections dueto the poor tradeoff with a more visible surgical scar.

More recently, electromagnetic medical devices that create a reversethermal gradient (i.e., Thermage) have attempted with variable successto tighten skin without surgery. At this time, these electromagneticdevices are best deployed in patients with a moderate amount of skinlaxity. Because of the limitations of electromagnetic devices andpotential side effects of surgery, a minimally invasive technology isneeded to circumvent surgically related scarring and the clinicalvariability of electromagnetic heating of the skin. For many patientswho have age related skin laxity (neck and face, arms, axillas, thighs,knees, buttocks, abdomen, bra line, ptosis of the breast), fractionalresection of excess skin could augment a significant segment oftraditional plastic surgery.

Even more significant than aesthetic modification of the skin envelopeis the surgical management of burns and other trauma related skindefects. Significant burns are classified by the total body surfaceburned and by the depth of thermal destruction. First-degree andsecond-degree burns are generally managed in a non-surgical fashion withthe application of topical creams and burn dressings. Deeperthird-degree burns involve the full thickness thermal destruction of theskin. The surgical management of these serious injuries involves thedebridement of the burn eschar and the application of split thicknessgrafts.

Any full thickness skin defect, most frequently created from burning,trauma, or the resection of a skin malignancy, can be closed with eitherskin flap transfers or skin grafts using current commercialinstrumentation. Both surgical approaches require harvesting from adonor site. The use of a skin flap is further limited by the need of toinclude a pedicle blood supply and in most cases by the need to directlyclose the donor site.

The split thickness skin graft procedure, due to immunologicalconstraints, requires the harvesting of autologous skin grafts, that is,from the same patient. Typically, the donor site on the burn patient ischosen in a non-burned area and a partial thickness sheet of skin isharvested from that area. Incumbent upon this procedure is the creationof a partial thickness skin defect at the donor site. This donor sitedefect is itself similar to a deep second-degree burn. Healing byre-epithelialization of this site is often painful and may be prolongedfor several days. In addition, a visible donor site deformity is createdthat is permanently thinner and more de-pigmented than the surroundingskin. For patients who have burns over a significant surface area, theextensive harvesting of skin grafts may also be limited by theavailability of non-burned areas.

For these reasons, there is a need in the rapidly expanding aestheticmarket for instrumentation and procedures for aesthetic surgical skintightening. There is also a need for systems, instruments or devices,and procedures that enable the repeated harvesting of skin grafts fromthe same donor site while eliminating donor site deformity.

INCORPORATION BY REFERENCE

Each patent, patent application, and/or publication mentioned in thisspecification is herein incorporated by reference in its entirety to thesame extent as if each individual patent, patent application, and/orpublication was specifically and individually indicated to beincorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows the PAD Kit placed at a target site, under an embodiment.

FIG. 2 is a cross-section of a scalpet punch or device including ascalpet array, under an embodiment.

FIG. 3 is a partial cross-section of a scalpet punch or device includinga scalpet array, under an embodiment.

FIG. 4 shows the adhesive membrane with backing (adherent substrate)included in a PAD Kit, under an embodiment.

FIG. 5 shows the adhesive membrane (adherent substrate) when used withthe PAD Kit frame and blade assembly, under an embodiment.

FIG. 6 shows the removal of skin pixels, under an embodiment.

FIG. 7 is a side view of blade transection and removal of incised skinpixels with the PAD Kit, under an embodiment.

FIG. 8 is an isometric view of blade/pixel interaction during aprocedure using the PAD Kit, under an embodiment.

FIG. 9 is another view during a procedure using the PAD Kit (bladeremoved for clarity) showing both harvested skin pixels or plugstransected and captured and non-transected skin pixels or plugs prior totransection, under an embodiment.

FIG. 10A is a side view of a portion of the pixel array showing scalpetssecured onto an investing plate, under an embodiment.

FIG. 10B is a side view of a portion of the pixel array showing scalpetssecured onto an investing plate, under an alternative embodiment.

FIG. 10C is a top view of the scalpet plate, under an embodiment.

FIG. 10D is a close view of a portion of the scalpet plate, under anembodiment.

FIG. 11A shows an example of rolling pixel drum, under an embodiment.

FIG. 11B shows an example of a rolling pixel drum assembled on a handle,under an embodiment.

FIG. 11C depicts a drum dermatome for use with the scalpet plate, underan embodiment.

FIG. 12A shows the drum dermatome positioned over the scalpet plate,under an embodiment.

FIG. 12B is an alternative view of the drum dermatome positioned overthe scalpet plate, under an embodiment.

FIG. 13A is an isometric view of application of the drum dermatome(e.g., Padgett dermatome) over the scalpet plate, where the adhesivemembrane is applied to the drum of the dermatome before rolling it overthe investing plate, under an embodiment.

FIG. 13B is a side view of a portion of the drum dermatome showing ablade position relative to the scalpet plate, under an embodiment.

FIG. 13C is a side view of the portion of the drum dermatome showing adifferent blade position relative to the scalpet plate, under anembodiment.

FIG. 13D is a side view of the drum dermatome with another bladeposition relative to the scalpet plate, under an embodiment.

FIG. 13E is a side view of the drum dermatome with the transection bladeclip showing transection of skin pixels by the blade clip, under anembodiment.

FIG. 13F is a bottom view of the drum dermatome along with the scalpetplate, under an embodiment.

FIG. 13G is a front view of the drum dermatome along with the scalpetplate, under an embodiment.

FIG. 13H is a back view of the drum dermatome along with the scalpetplate, under an embodiment.

FIG. 14A shows an assembled view of the dermatome with the Pixel OnlaySleeve (POS), under an embodiment.

FIG. 14B is an exploded view of the dermatome with the Pixel OnlaySleeve (POS), under an embodiment.

FIG. 14C shows a portion of the dermatome with the Pixel Onlay Sleeve(POS), under an embodiment.

FIG. 15A shows the Slip-On PAD being slid onto a Padgett Drum Dermatome,under an embodiment.

FIG. 15B shows an assembled view of the Slip-On PAD installed over thePadgett Drum Dermatome, under an embodiment.

FIG. 16A shows the Slip-On PAD installed over a Padgett Drum Dermatomeand used with a perforated template or guide plate, under an embodiment.

FIG. 16B shows skin pixel harvesting with a Padgett Drum Dermatome andinstalled Slip-On PAD, under an embodiment.

FIG. 17A shows an example of a Pixel Drum Dermatome being applied to atarget site of the skin surface, under an embodiment.

FIG. 17B shows an alternative view of a portion of the Pixel DrumDermatome being applied to a target site of the skin surface, under anembodiment.

FIG. 18 shows a side perspective view of the PAD assembly, under anembodiment.

FIG. 19A shows a top perspective view of the scalpet device for use withthe PAD assembly, under an embodiment.

FIG. 19B shows a bottom perspective view of the scalpet device for usewith the PAD assembly, under an embodiment.

FIG. 20 shows a side view of the punch impact device including a vacuumcomponent, under an embodiment.

FIG. 21A shows a top view of an oscillating flat scalpet array and bladedevice, under an embodiment.

FIG. 21B shows a bottom view of an oscillating flat scalpet array andblade device, under an embodiment.

FIG. 21C is a close-up view of the flat array when the array ofscalpets, blades, adherent membrane and the adhesive backer areassembled together, under an embodiment.

FIG. 21D is a close-up view of the flat array of scalpets with a feedercomponent, under an embodiment.

FIG. 22 shows a cadaver dermal matrix cylindrically transected similarin size to the harvested skin pixel grafts, under an embodiment.

FIG. 23 is a drum array drug delivery device, under an embodiment.

FIG. 24A is a side view of a needle array drug delivery device, under anembodiment.

FIG. 24B is an upper isometric view of a needle array drug deliverydevice, under an embodiment.

FIG. 24C is a lower isometric view of a needle array drug deliverydevice, under an embodiment.

FIG. 25 shows the composition of human skin.

FIG. 26 shows the physiological cycles of hair growth.

FIG. 27 shows harvesting of donor follicles, under an embodiment.

FIG. 28 shows preparation of the recipient site, under an embodiment.

FIG. 29 shows placement of the harvested hair plugs at the recipientsite, under an embodiment.

FIG. 30 shows placement of the perforated plate on the occipital scalpdonor site, under an embodiment.

FIG. 31 shows scalpet penetration depth through skin when the scalpet isconfigured to penetrate to the subcutaneous fat layer to capture thehair follicle, under an embodiment.

FIG. 32 shows hair plug harvesting using the perforated plate at theoccipital donor site, under an embodiment.

FIG. 33 shows creation of the visible hairline, under an embodiment.

FIG. 34 shows preparation of the donor site using the patternedperforated plate and spring-loaded pixilation device to create identicalskin defects at the recipient site, under an embodiment.

FIG. 35 shows transplantation of harvested plugs by inserting harvestedplugs into a corresponding skin defect created at the recipient site,under an embodiment.

FIG. 36 shows a clinical end point using the pixel dermatomeinstrumentation and procedure, under an embodiment.

FIG. 37 is an image of the skin tattooed at the corners and midpoints ofthe area to be resected, under an embodiment.

FIG. 38 is an image of the post-operative skin resection field, under anembodiment.

FIG. 39 is an image at 11 days following the procedure showingresections healed per primum, with measured margins, under anembodiment.

FIG. 40 is an image at 29 days following the procedure showingresections healed per primum and maturation of the resection fieldcontinuing per primum, with measured margins, under an embodiment.

FIG. 41 is an image at 29 days following the procedure showingresections healed per primum and maturation of the resection fieldcontinuing per primum, with measured lateral dimensions, under anembodiment.

FIG. 42 is an image at 90 days post-operative showing resections healedper primum and maturation of the resection field continuing per primum,with measured lateral dimensions, under an embodiment.

FIG. 43 is a scalpet showing the applied rotational and/or impactforces, under an embodiment.

FIG. 44 shows a geared scalpet and an array including geared scalpets,under an embodiment.

FIG. 45 is a bottom perspective view of a resection device including thescalpet assembly with geared scalpet array, under an embodiment.

FIG. 46 is a bottom perspective view of the scalpet assembly with gearedscalpet array (housing not shown), under an embodiment.

FIG. 47 is a detailed view of the geared scalpet array, under anembodiment.

FIG. 48 shows an array including scalpets in a frictional driveconfiguration, under an embodiment.

FIG. 49 shows a helical scalpet (external) and an array includinghelical scalpets (external), under an embodiment.

FIG. 50 shows side perspective views of a scalpet assembly including ahelical scalpet array (left), and the resection device including thescalpet assembly with helical scalpet array (right) (housing shown),under an embodiment.

FIG. 51 is a side view of a resection device including the scalpetassembly with helical scalpet array assembly (housing depicted astransparent for clarity of details), under an embodiment.

FIG. 52 is a bottom perspective view of a resection device including thescalpet assembly with helical scalpet array assembly (housing depictedas transparent for clarity of details), under an embodiment.

FIG. 53 is a top perspective view of a resection device including thescalpet assembly with helical scalpet array assembly (housing depictedas transparent for clarity of details), under an embodiment.

FIG. 54 is a push plate of the helical scalpet array, under anembodiment.

FIG. 55 shows the helical scalpet array with the push plate, under anembodiment.

FIG. 56 shows an inner helical scalpet and an array including innerhelical scalpets, under an embodiment.

FIG. 57 shows the helical scalpet array with the drive plate, under anembodiment.

FIG. 58 shows a slotted scalpet and an array including slotted scalpets,under an embodiment.

FIG. 59 shows a portion of a slotted scalpet array (e.g., four (4)scalpets) with the drive rod, under an embodiment.

FIG. 60 shows an example slotted scalpet array (e.g., 25 scalpets) withthe drive rod, under an embodiment.

FIG. 61 shows an oscillating pin drive assembly with a scalpet, under anembodiment.

FIG. 62 shows variable scalpet exposure control with the scalpet guideplates, under an embodiment.

FIG. 63 shows a scalpet assembly including a scalpet array (e.g.,helical) configured to be manually driven by an operator, under anembodiment.

FIG. 64 shows forces exerted on a scalpet via application to the ski.

FIG. 65 depicts steady axial force compression using a scalpet, under anembodiment.

FIG. 66 depicts steady single axial force compression plus kineticimpact force using a scalpet, under an embodiment.

FIG. 67 depicts moving of the scalpet at a velocity to impact and piercethe skin, under an embodiment.

FIG. 68 depicts a multi-needle tip, under an embodiment.

FIG. 69 shows a square scalpet without teeth (left), and a squarescalpet with multiple teeth (right), under an embodiment.

FIG. 70 shows multiple side, front (or back), and side perspective viewsof a round scalpet with an oblique tip, under an embodiment.

FIG. 71 shows a round scalpet with a serrated edge, under an embodiment.

FIG. 72 shows a side view of the resection device including the scalpetassembly with scalpet array and extrusion pins (housing depicted astransparent for clarity of details), under an embodiment.

FIG. 73 shows a top perspective cutaway view of the resection deviceincluding the scalpet assembly with scalpet array and extrusion pins(housing depicted as transparent for clarity of details), under anembodiment.

FIG. 74 shows side and top perspective views of the scalpet assemblyincluding the scalpet array and extrusion pins, under an embodiment.

FIG. 75 is a side view of a resection device including the scalpetassembly with scalpet array assembly coupled to a vibration source,under an embodiment.

FIG. 76 shows a scalpet array driven by an electromechanical source orscalpet array generator, under an embodiment.

FIG. 77 is a diagram of the resection device including a vacuum system,under an embodiment.

FIG. 78 shows a vacuum manifold applied to a target skin surface toevacuate/harvest excised skin/hair plugs, under an embodiment.

FIG. 79 shows a vacuum manifold with an integrated wire mesh applied toa target skin surface to evacuate/harvest excised skin/hair plugs, underan embodiment.

FIG. 80 shows a vacuum manifold with an integrated wire mesh configuredto vacuum subdermal fat, under an embodiment.

FIG. 81 depicts a collapsible docking station and an inserted skinpixel, under an embodiment. The docking station is formed fromelastomeric material but is not so limited.

FIG. 82 is a top view of a docking station (e.g., elastomeric) instretched (left) and un-stretched (right) configuration, under anembodiment, under an embodiment.

FIG. 83 depicts removal of lax excess skin without apparent scarring,under an embodiment.

FIG. 84 depicts tightening of skin without apparent scaring, under anembodiment.

FIG. 85 depicts three-dimensional contouring of the skin envelop, underan embodiment.

FIG. 86 depicts variable fractional resection densities in a treatmentarea, under an embodiment.

FIG. 87 depicts fractional resection of fat, under an embodiment.

FIG. 88 depicts cobblestoning of the skin surface.

FIG. 89 depicts topographic mapping for a deeper level of fractional fatresection, under an embodiment.

FIG. 90 depicts multiple treatment outlines, under an embodiment.

FIG. 91 depicts a curvilinear treatment pattern, under an embodiment.

FIG. 92 depicts a digital image of a patient with rendered digital wiremesh program, under an embodiment.

FIG. 93 depicts directed closure of a fractionally resected field, underan embodiment.

FIG. 94 depicts directed fractional resection of skin, under anembodiment.

FIG. 95 depicts shortening of incisions through continuity fractionalprocedures, under an embodiment.

FIG. 96 is an example depiction of “dog ear” skin redundancies in breastreduction and abdominoplasty.

FIG. 97 is a sPAD including a skived single scalpet with depth control,under an embodiment.

FIG. 98 is a sPAD including a standard single scalpet, under anembodiment.

FIG. 99 is a sPAD including a pencil-style gear reducing handpiece,under an embodiment.

FIG. 100 is a sPAD including a 3×3 centerless array, under anembodiment.

FIG. 101 is a sPAD including a cordless surgical drill for large arrays,under an embodiment.

FIG. 102 is a sPAD comprising a drill mounted 5×5 centerless array,under an embodiment.

FIG. 103 is a sPAD including a vacuum assisted pneumatic resection sPAD,under an embodiment.

FIG. 104 is a VAPR sPAD coupled to a drill via a DAC, under anembodiment.

FIG. 105 depicts the VAPR sPAD in a ready state (left), and an extendedtreatment state (right), under an embodiment.

FIG. 106 depicts the SAVR sPAD in a ready state (left), and a retractedstate (right), under an embodiment.

FIG. 107A is a cross-sectional side view of a vacuum aspiratorconfigured to be coupled or attached in series with a vacuum manifoldand scalpet array, under an embodiment.

FIG. 107B is an isometric cross-sectional view of a vacuum aspiratorconfigured to be coupled or attached in series with a vacuum manifoldand scalpet array, under an embodiment.

FIG. 107C is a solid side view of a vacuum aspirator configured to becoupled or attached in series with a vacuum manifold and scalpet array,under an embodiment.

FIG. 108A is a cross-sectional side view of a scalpet array used with avacuum aspirator, under an embodiment.

FIG. 108B is an isometric cross-sectional view of a scalpet array usedwith a vacuum aspirator, under an embodiment.

FIG. 108C is a solid side view of a scalpet array used with a vacuumaspirator, under an embodiment.

FIG. 109A is a cross-sectional side view of a vacuum manifold configuredto be coupled or connected to a vacuum aspirator, under an embodiment.

FIG. 109B is an isometric cross-sectional view of a vacuum manifoldconfigured to be coupled or attached to a vacuum aspirator, under anembodiment.

FIG. 109C is a solid side view of a vacuum manifold configured to becoupled or attached to a vacuum aspirator, under an embodiment.

FIG. 110 is a solid side view of the device with the vacuum componentconfigured for manual control via an aperture, under an embodiment.

FIG. 111A is an isometric view of a handpiece configured to include orincorporate vacuum, under an embodiment.

FIG. 111B is an isometric cutaway view of the handpiece configured toinclude or incorporate vacuum, under an embodiment.

FIG. 112 is a cross-sectional side view of a single-scalpet deviceapplied to a target tissue site, under an embodiment.

FIG. 113 is an isometric cross-sectional view of a single-scalpet deviceapplied to a target tissue site, under an embodiment.

FIG. 114A is a cross-sectional side view of a multi-scalpet deviceapplied to a target tissue site, under an embodiment.

FIG. 114B is an isometric cross-sectional view of a multi-scalpet deviceapplied to a target tissue site, under an embodiment.

FIG. 115 is an example slotted scalpet, under an embodiment.

FIG. 116 is an example slotted blunt micro-tip cannula, under anembodiment.

FIG. 117 is an example ink stencil marking system, under an embodiment.

FIG. 118 shows the adherent semitransparent perforated plastic membrane,under an embodiment.

FIG. 1193A shows a side view of the ASPPMP in use as a depth guide withthe single-scalpet device, under an embodiment.

FIG. 119B shows a top isometric view of the ASPPMP in use as a depthguide with the single-scalpet device, under an embodiment.

FIG. 120 shows fractional resection of skin and fractionalsubdermal/subcutaneous lipectomy, under an embodiment.

FIG. 121 shows a side view of the submentum as a target area forfractional resection of skin and fractional subdermal/subcutaneouslipectomy, under an embodiment.

FIG. 122 shows an inferior view (looking upward) of the fractionalresection field submentum as a target area for fractional resection ofskin and fractional subdermal/subcutaneous lipectomy, under anembodiment.

FIG. 123 shows a horizontally aligned treatment area in the submentumand lateral neck for severe skin laxity, under an embodiment.

FIG. 124 shows broader fractional lipectomy in the submentum for severelipodystrophy, under an embodiment.

FIG. 125 shows example face vector and neck vector directed closures,under an embodiment.

FIG. 126 shows Langer's lines of closure.

FIG. 127 shows marked target areas for fractional resection of neck andsubmental lipectomy, under an embodiment.

FIG. 128 shows an example stencil, under an embodiment.

FIG. 129 shows example directed closure vectors of the submentum andanterior neck, under an embodiment.

FIG. 130 depicts Z-plasty and W-plasty scar revision.

FIG. 131 shows an example of the fractional de-delineation technique ofscar resection, under an embodiment.

FIG. 132 shows an example of the fractional scar resection for broadhypotrophic scars, under an embodiment.

FIG. 133 shows an example comprising shortening of the inframmaryincision as applied to breast reduction and/or breast repositioning,under an embodiment.

FIG. 134 shows an example flap closure.

FIG. 135 shows an example comprising fractional skin graft harvesting tobe applied to a donor site, under an embodiment.

FIG. 136 shows an example comprising neovascularization of a fractionalskin graft at a recipient site, under an embodiment.

FIG. 137 shows an example docking station comprising a docking tray andadjustable slides, under an embodiment.

FIG. 138 shows a face having target tissue that includes, for example,furrows and folds.

FIG. 139 shows a fractionally incised field (skin plugs insitu), underan embodiment.

FIG. 140 is a detailed view of fractional skin resection defectharvesting, under an embodiment.

FIG. 141 shows an example with skin plugs harvested using a membraneapplied directly to a drum dermatome, under an embodiment.

FIG. 142 shows removal of the epidermal component by transecting theskin plugs generated by the dermatome with an outrigger blade of thedermatome, under an embodiment.

FIG. 143 shows skin plugs separately harvested onto a membrane, and themembrane is then applied to a dermatome (e.g., drum), under anembodiment.

FIG. 144 shows a non-compressive moreselizer configured to mechanicallymince the dermal plugs into a viscous liquid, under an embodiment.

FIG. 145 shows injection of the LADMIX filler at a target tissue site,under an embodiment.

FIG. 146 shows an example of a scalpet device including amulti-functional chamber, under an embodiment.

FIG. 147 shows an example vacuum flow path through the scalpet device,under an embodiment.

FIG. 148 shows an example scalpet device following collection of pixelsin the collection chamber, under an embodiment.

FIG. 149 shows an inverted handpiece with pixels in the collectionchamber, under an embodiment.

FIG. 150 shows the inverted handpiece with the alternative end cap andfitting plug installed, under an embodiment.

FIG. 151 shows the handpiece with mincing blade attached and positionedin the collection chamber with the pixel solution, under an embodiment.

FIG. 152 shows the LADMIX filler drawn into the syringe, under anembodiment.

FIG. 153 shows the syringe and attached needle readied for injecting theLADMIX filler into the target tissue site, under an embodiment.

FIG. 154 shows a skin blister formed within an entire fractional field,under an embodiment.

FIG. 155 shows the fractional field following removal of the blisteredtissue overlying the entire fractional field, under an embodiment.

FIG. 156 shows formation of multiple skin blisters, under an embodiment.

FIG. 157 shows multiple fractional fields following removal of theblistered tissue overlying the fractional fields, under an embodiment.

FIG. 158 shows harvesting of dermal plugs within a blistered regionusing a single scalpet system or a multiple scalpet array, under anembodiment.

FIG. 159 shows a collection vessel or canister including harvesteddermal plugs, under an embodiment.

FIG. 160 shows a mincer container or canister including harvested dermalplugs, under an embodiment.

FIG. 161 shows a manual mincer including a blade device configured to bemanipulated up/down and/or rotated, under an embodiment.

FIG. 162 shows an electric mincer including a blade or cutting deviceconfigured to be rotated under power, under an embodiment.

FIG. 163 is an example marking system template, under an embodiment.

FIG. 164 shows creation of the recipient pocket for the injectable,under an embodiment.

FIG. 165 the recipient pocket with the injected filler, under anembodiment.

FIG. 166 shows treatment of female incontinence using injection ofLADMIX, under an embodiment.

DETAILED DESCRIPTION

Systems, instruments, methods, and compositions are described involvingremoving a portion of the epidermis within a donor site on a subject,and harvesting dermal plugs within the donor site. An injectable filleris formed by mincing the dermal plugs. The injectable filler isconfigured for injecting into a recipient site on the subject.

Systems, instruments, and methods are described in which a scalpetdevice comprises a housing configured to include a scalpet assembly. Thescalpet assembly includes a scalpet array and one or more guide plates.The scalpet array includes a set of scalpets, and in embodiments the setof scalpets include multiple scalpets. The guide plate maintains aconfiguration of the set of scalpets. The set of scalpets is configuredto be deployed from and retracted into the housing, and is configured togenerate incised skin pixels at a target site when deployed. The incisedskin pixels are harvested.

The scalpet device described herein satisfies the expanding aestheticmarket for instrumentation and procedures for aesthetic surgical skintightening. Additionally, the embodiments enable the repeated harvestingof skin grafts from the same donor site while eliminating donor sitedeformity. The embodiments described herein are configured to resectredundant lax skin without visible scarring so that all areas ofredundant skin laxity can be resected by the pixel array dermatome andprocedures may be performed in areas that were previously off limits dueto the visibility of the surgical incision. The technical effectsrealized through the embodiments described herein include smooth,tightened skin without visible scarring or long scars along anatomicalborders.

Embodiments described in detail herein, which include pixel skingrafting instrumentation and methods, are configured to provide thecapability to repeatedly harvest split thickness skin grafts withoutvisible scarring of the donor site. During the procedure, a Pixel ArrayDermatome (PAD) is used to harvest the skin graft from the chosen donorsite. During the harvesting procedure, a pixilated skin graft isdeposited onto a flexible, semi-porous, adherent membrane. The harvestedskin graft/membrane composite is then applied directly to the recipientskin defect site. The fractionally resected donor site is closed withthe application of an adherent sheeting or bandage (e.g., Flexzan®sheeting, etc.) that functions for a period of time (e.g., one week,etc.) as a large butterfly bandage. The intradermal skin defectsgenerated by the PAD are closed to promote a primary healing process inwhich the normal epidermal-dermal architecture is realigned in ananatomical fashion to minimize scarring. Also occurring postoperatively,the adherent membrane is desquamated (shed) with the stratum corneum ofthe graft; the membrane can then be removed without disruption of thegraft from the recipient bed.

Numerous effects realized by the pixel skin grafting procedure deserveexplanation. Because the skin graft is pixelated it provides intersticesfor drainage between skin plug components, which enhances the percentageof “takes,” compared to sheet skin grafts. During the firstpost-operative week, the skin graft “takes” at the recipient site by aprocess of neovascularization in which new vessels from the recipientbed of the skin defect grow into the new skin graft. The semiporousmembrane conducts the exudate into the dressing.

The flexible membrane is configured with an elastic recoil property thatpromotes apposition of component skin plugs within the graft/membranecomposite; promoting primary adjacent healing of the skin graft plugsand converting the pixilated appearance of the skin graft into a moreuniform sheet morphology. Furthermore, the membrane aligns themicro-architectural components skin plugs, so epidermis aligns withepidermis and dermis aligns with dermis, promoting a primary healingprocess that reduces scarring.

There are numerous major clinical applications for the dermatomesdescribed in detail herein, including fractional skin resection for skintightening, fractional hair grafting for alopecia, and fractional skinharvesting for skin grafting. Fractional skin resection of an embodimentcomprises harvesting skin plugs using an adherent membrane, however thefractionally incised skin plugs can be evacuated without harvesting. Theparadigm of incising, evacuating and closing is most descriptive of theclinical application of skin tightening. The embodiments describedherein are configured to facilitate incising and evacuating and, inorder to provide for a larger scalpet array with a greater number ofscalpets, the embodiments include a novel means of incising the skinsurface.

Pixel array medical systems, instruments or devices, and methods aredescribed for skin grafting and skin resection procedures, and hairtransplantation procedures. In the following description, numerousspecific details are introduced to provide a thorough understanding of,and enabling description for, embodiments herein. One skilled in therelevant art, however, will recognize that these embodiments can bepracticed without one or more of the specific details, or with othercomponents, systems, etc. In other instances, well-known structures oroperations are not shown, or are not described in detail, to avoidobscuring aspects of the disclosed embodiments.

The following terms are intended to have the following general meaningas they may be used herein. The terms are not however limited to themeanings stated herein as the meanings of any term can include othermeanings as understood or applied by one skilled in the art.

“First degree burn” as used herein includes a superficial thermal injuryin which there is no disruption of the epidermis from the dermis. Afirst-degree burn is visualized as erythema (redness) of the skin.

“Second degree burn” as used herein includes a relatively deeper burn inwhich there is disruption of the epidermis from the dermis and where avariable thickness of the dermis is also denatured. Most second-degreeburns are associated with blister formation. Deep second-degree burnsmay convert to full thickness third degree burns, usually by oxidationor infection.

“Third degree burn” as used herein includes a burn associated with thefull thickness thermal destruction of the skin including the epidermisand the dermis. A third degree burn may also be associated with thermaldestruction of deeper, underlying tissues (subcutaneous and musclelayers).

“Ablation” as used herein includes the removal of tissue by destructionof the tissue e.g., thermal ablation of a skin lesion by a laser.

“Autograft” as used herein includes a graft taken from the same patient.

“Backed Adherent Membrane” as used herein includes the elastic adherentmembrane that captures the transected skin plugs. The Backed AdherentMembrane of an embodiment is backed on the outer surface to retainalignment of the skin plugs during harvest. After harvesting of the skinplugs, the backing is removed from the adherent membrane with harvestedskin plugs. The membrane of an embodiment is porous to allow fordrainage when placed at the recipient site. The membrane of anembodiment also possesses an elastic recoil property, so that when thebacking is removed, it brings the sides of the skin plugs closer to eachother to promote healing at the recipient site as a sheet graft.

“Burn Scar Contraction” as used herein includes the tightening of scartissue that occurs during the wound healing process. This process ismore likely to occur with an untreated third degree burn.

“Burn Scar Contracture” as used herein includes a band of scar tissuethat either limits the range of motion of a joint or band of scar tissuethat distorts the appearance of the patient i.e., a burn scarcontracture of the face.

“Dermatome” as used herein includes an instrument that “cuts skin” orharvests a sheet split thickness skin graft. Examples of drum dermatomesinclude the Padgett and Reese dermatomes. Electrically powereddermatomes are the Zimmer dermatome and one electric version of thePadgett dermatome.

“Dermis” as used herein includes the deep layer of skin that is the mainstructural support and primarily comprises non-cellular collagen fibers.Fibroblasts are cells in the dermis that produce the collagen proteinfibers.

“Donor Site” as used herein includes the anatomical site from which askin graft is harvested.

“Epidermis” as used herein includes the outer layer of skin comprisingviable epidermal cells and nonviable stratum corneum that acts as abiological barrier.

“Excise” as used herein includes the surgical removal of tissue.

“Excisional Skin Defect” as used herein includes a partial thickness or,more typically, a full thickness defect that results from the surgicalremoval (excision/resection) of skin (lesion).

“FTSG” as used herein includes a Full Thickness Skin Graft in which theentire thickness of the skin is harvested. With the exception of aninstrument as described herein, the donor site is closed as a surgicalincision. For this reason, FTSG is limited in the surface area that canbe harvested.

“Granulation Tissue” as used herein includes highly vascularized tissuethat grows in response to the absence of skin in a full-thickness skindefect. Granulation Tissue is the ideal base for a skin graft recipientsite.

“Healing by primary intention” as used herein includes the wound healingprocess in which normal anatomical structures are realigned with aminimum of scar tissue formation. Morphologically the scar is lesslikely to be visible.

“Healing by secondary intention” as used herein includes a lessorganized wound healing process wherein healing occurs with lessalignment of normal anatomical structures and with an increaseddeposition of scar collagen. Morphologically, the scar is more likely tobe visible.

“Homograft” as used herein includes a graft taken from a different humanand applied as a temporary biological dressing to a recipient site on apatient. Most homografts are harvested as cadaver skin. A temporary“take” of a homograft can be partially achieved with immunosuppressionbut homografts are eventually replaced by autografts if the patientsurvives.

“Incise” as used herein includes the making of a surgical incisionwithout removal of tissue.

“Mesh Split Thickness Skin Graft” as used herein includes a splitthickness skin graft that is expanded in its surface area byrepetitiously incising the harvested skin graft with an instrumentcalled a “mesher”. A meshed split thickness skin graft has a higherpercentage of “take” than a sheet graft because it allows drainagethrough the graft and conforms better to the contour irregularities ofthe recipient site. However, it does result in an unsightly reticulatedappearance of the graft at the recipient site.

“PAD” as used herein includes a Pixel Array Dermatome, the class ofinstruments for fractional skin resection.

“PAD Kit” as used herein includes the disposable single use procedurekit comprising the perforated guide plate, scalpet stamper, the guideplate frame, the backed adherent membrane and the transection blade.

“Perforated Guide Plate” as used herein includes a perforated platecomprising the entire graft harvest area in which the holes of the guideplate are aligned with the scalpets of the handled stamper or theSlip-on PAD. The plate will also function as a guard to preventinadvertent laceration of the adjacent skin. The perforations of theGuide Plate can be different geometries such as, but not limited to,round, oval, square. rectangular, and/or triangular.

“Pixelated Full Thickness Skin Graft” as used herein includes a FullThickness Skin Graft that has been harvested with an instrument asdescribed herein without reduced visibly apparent scarring at the donorsite. The graft will also possess an enhanced appearance at therecipient site similar to a sheet FTSG but will conform better torecipient site and will have a higher percentage of ‘take’ due todrainage interstices between skin plugs. Another significant advantageof the pixelated FTSG in comparison to a sheet FTSG is the ability tograft larger surface areas that would otherwise require a STSG. Thisadvantage is due to the capability to harvest from multiple donor siteswith reduced visible scarring.

“Pixelated Graft Harvest” as used herein includes the skin graftharvesting from a donor site by an instrument as described in detailherein.

“Pixelated Spilt Thickness Skin Graft” as used herein includes a partialthickness skin graft that has been harvested with an SRG instrument. Theskin graft shares the advantages of a meshed skin graft withoutunsightly donor and recipient sites.

“Recipient Site” as used herein includes the skin defect site where askin graft is applied.

“Resect” as used herein includes excising.

“Scalpel” as used herein includes the single-edged knife that incisesskin and soft tissue.

“Scalpet” as used herein includes the term that describes the smallgeometrically-shaped (e.g., circle, ellipse, rectangle, square, etc.)scalpel that incises a plug of skin.

“Scalpet Array” as used herein includes the arrangement or array ofmultiple scalpets secured to a substrate (e.g., a base plate, stamper,handled stamper, tip, disposable tip, etc.).

“Scalpet Stamper” as used herein includes a handled scalpet arrayinstrument component of the PAD Kit that incises skin plugs through theperforated guide plate.

“Scar” as used herein includes the histological deposition ofdisorganized collagen following wounding, or the morphological deformitythat is visually apparent from the histological deposition ofdisorganized collagen following wounding.

“Sheet Full Thickness Skin Graft” as used herein includes reference toapplication of the FTSG at the recipient site as continuous sheet. Theappearance of an FTSG is superior to the appearance of a STSG and forthis reason it is primarily used for skin grafting in visually apparentareas such as the face.

“Sheet Split Thickness Skin Graft” as used herein includes a partialthickness skin graft that is a continuous sheet and is associated withthe typical donor site deformity.

“Skin Defect” as used herein includes the absence of the full thicknessof skin that may also include the subcutaneous fat layer and deeperstructures such as muscle. Skin defects can occur from a variety ofcauses i.e., burns, trauma, surgical excision of malignancies and thecorrection of congenital deformities.

“Skin Pixel” as used herein includes a piece of skin comprisingepidermis and a partial or full thickness of the dermis that is cut bythe scalpet; the skin pixel may include skin adnexa such as a hairfollicle with or without a cuff of subcutaneous fat; also includes SkinPlug.

“Skin Plug” as used herein includes a circular (or other geometricshaped) piece of skin comprising epidermis and a partial or fullthickness of the dermis that is incised by the scalpet, transected bythe transection blade and captured by the adherent-backed membrane.

“STSG” as used herein includes the Partial Thickness Skin Graft in whichthe epidermis and a portion of the dermis is harvested with the graft.

“Subcutaneous Fat Layer” as used herein includes the layer that isimmediately below the skin and is principally comprised of fat cellsreferred to as lipocytes. This layer functions as principle insulationlayer from the environment.

“Transection Blade” as used herein includes a horizontally-alignedsingle edged blade that can be either slotted to the frame of theperforated plate or attached to the outrigger arm of the drum dermatomeas described in detail herein. The transection blade transects the baseof the incised skin plugs.

“Wound Healing” as used herein includes the obligate biological processthat occurs from any type of wounding whether it be one or more ofthermal, kinetic and surgical.

“Xenograft” as used herein includes a graft taken from a differentspecies and applied as a temporary biological dressing to a recipientsite on a patient.

Multiple embodiments of pixel array medical systems, instruments ordevices, and methods for use are described in detail herein. Thesystems, instruments or devices, and methods described herein compriseminimally invasive surgical approaches for skin grafting and for skinresection that tightens lax skin without visible scarring via a deviceused in various surgical procedures such as plastic surgery procedures,and additionally for hair transplantation. In some embodiments, thedevice is a single use disposable instrument. The embodiments hereincircumvent surgically related scarring and the clinical variability ofelectromagnetic heating of the skin and perform small multiple pixilatedresections of skin as a minimally invasive alternative to large plasticsurgical resections of skin. The embodiments herein can also be employedin hair transplantation, and in areas of the body that may be off limitsto plastic surgery due to the visibility of the surgical scar. Inaddition, the approach can perform a skin grafting operation byharvesting the transected incisions of skin from a tissue site of adonor onto a skin defect site of a recipient with reduced scarring ofthe patients donor site.

For many patients who have age related skin laxity (for non-limitingexamples, neck and face, arms, axillas, thighs, knees, buttocks,abdomen, bra line, ptosis of the breast, etc.), the minimally invasivepixel array medical devices and methods herein perform pixilatedtransection/resection of excess skin, replacing plastic surgery with itsincumbent scarring. Generally, the procedures described herein areperformed in an office setting under a local anesthetic with minimalperioperative discomfort, but are not so limited. In comparison to aprolonged healing phase from plastic surgery, only a short recoveryperiod is required, preferably applying a dressing and a support garmentworn over the treatment area for a pre-specified period of time (e.g., 5days, 7 days, etc.). There will be minimal or no pain associated withthe procedure.

The relatively small (e.g., in a range of approximately 0.5 mm to 4.0mm) skin defects generated by the instrumentation described herein areclosed with the application of an adherent sheet (e.g., Flexan®).Functioning as a large butterfly bandage, the adherent sheet (e.g.,Flexan®) can be pulled in a direction (“vector”) that maximizes theaesthetic contouring of the treatment area. A compressive elasticgarment is applied over the dressing to further assist aestheticcontouring. After completion of the initial healing phase, themultiplicity of small linear scars within the treatment area will havereduced visibility in comparison to larger plastic surgical incisions onthe same area. Additional skin tightening is likely to occur overseveral months due to the delayed wound healing response. Otherpotential applications of the embodiments described herein include hairtransplantation as well as the treatment of Alopecia, Snoring/Sleepapnea, Orthopedics/Physiatry, Vaginal Tightening, Female Urinaryincontinence, and tightening of gastrointestinal sphincters.

Significant burns are classified by the total body surface burned and bythe depth of thermal destruction, and the methods used to manage theseburns depend largely on the classification. First-degree andsecond-degree burns are usually managed in a non-surgical fashion withthe application of topical creams and burn dressings. Deeperthird-degree burns involve the full thickness thermal destruction of theskin, creating a full thickness skin defect. The surgical management ofthis serious injury usually involves the debridement of the burn escharand the application of split thickness grafts.

A full thickness skin defect, most frequently created from burning,trauma, or the resection of a skin malignancy, can be closed with eitherskin flap transfers or skin grafts using conventional commercialinstrumentation. Both surgical approaches require harvesting from adonor site. The use of a skin flap is further limited by the need of toinclude a pedicle blood supply and in most cases by the need to directlyclose the donor site.

The split thickness skin graft procedure, due to immunologicalconstraints, requires the harvesting of autologous skin grafts from thesame patient. Typically, the donor site on the burn patient is chosen ina non-burned area and a partial thickness sheet of skin is harvestedfrom that area. Incumbent upon this procedure is the creation of apartial thickness skin defect at the donor site. This donor site defectitself is similar to a deep second-degree burn. Healing byre-epithelialization of this site is often painful and may be prolongedfor several days. In addition, a visible donor site deformity istypically created that is permanently thinner and more de-pigmented thanthe surrounding skin. For patients who have burns over a significantsurface area, the extensive harvesting of skin grafts may also belimited by the availability of non-burned areas.

Both conventional surgical approaches to close skin defects (flaptransfer and skin grafting) are not only associated with significantscarring of the skin defect recipient site but also with the donor sitefrom which the graft is harvested. In contrast to the conventionalprocedures, embodiments described herein comprise Pixel Skin GraftingProcedures, also referred to as a pixel array procedures, that eliminatethis donor site deformity and provide a method to re-harvest skin graftsfrom any pre-existing donor site including either sheet or pixelateddonor sites. This ability to re-harvest skin grafts from pre-existingdonor sites will reduce the surface area requirement for donor site skinand provide additional skin grafting capability in severely burnedpatients who have limited surface area of unburned donor skin.

The Pixel Skin Grafting Procedure of an embodiment is used as a fullthickness skin graft. Many clinical applications such as facial skingrafting, hand surgery, and the repair of congenital deformities arebest performed with full thickness skin grafts. The texture,pigmentation and overall morphology of a full thickness skin graft moreclosely resembles the skin adjacent to a defect than a split thicknessskin graft. For this reason, full thickness skin grafting in visiblyapparent areas is superior in appearance than split thickness skingrafts. The main drawback to full thickness skin grafts underconventional procedures is the extensive linear scarring created fromthe surgical closure of the full thickness donor site defect; thisscarring limits the size and utility of full thickness skin grafting.

In comparison, the full thickness skin grafting of the Pixel SkinGrafting Procedure described herein is less limited by size and utilityas the linear donor site scar is eliminated. Thus, many skin defectsroutinely covered with split thickness skin grafts will instead betreated using pixelated full thickness skin grafts.

The Pixel Skin Grafting Procedure provides the capability to harvestsplit thickness and full thickness skin grafts with minimal visiblescarring of the donor site. During the procedure, a Pixel ArrayDermatome (PAD) device is used to harvest the skin graft from a chosendonor site. During the harvesting procedure, the pixilated skin graft isdeposited onto an adherent membrane. The adherent membrane of anembodiment includes a flexible, semi-porous, adherent membrane, but theembodiment is not so limited. The harvested skin graft/membranecomposite is then applied directly to the recipient skin defect site.The fractionally resected donor site is closed with the application ofan adherent sheet (e.g., Flexzan®) that functions for one week as alarge butterfly bandage. The relatively small (e.g., 1.5 mm) intradermalcircular skin defects are closed to promote a primary healing process inwhich the normal epidermal-dermal architecture is realigned in ananatomical fashion to minimize scarring. Also occurring approximatelyone week postoperatively, the adherent membrane is desquamated (shed)with the stratum corneum of the graft; the membrane can then be removedwithout disruption of the graft from the recipient bed. Thus, healing ofthe donor site occurs rapidly with minimal discomfort and scarring.

Because the skin graft at the recipient defect site using the Pixel SkinGrafting Procedure is pixelated it provides interstices for drainagebetween skin pixel components, which enhances the percentage of “takes,”compared to sheet skin grafts. During the first post-operative week(approximate), the skin graft will “take” at the recipient site by aprocess of neovascularization in which new vessels from the recipientbed of the skin defect grow into the new skin graft. The semi-porousmembrane will conduct the transudate (fluid) into the dressing.Furthermore, the flexible membrane is designed with an elastic recoilproperty that promotes apposition of component skin pixels within thegraft/membrane composite and promotes primary adjacent healing of theskin graft pixels, converting the pixilated appearance of the skin graftto a uniform sheet morphology. Additionally, the membrane aligns themicro-architectural component skin pixels, so epidermis aligns withepidermis and dermis aligns with dermis, promoting a primary healingprocess that reduces scarring. Moreover, pixelated skin grafts moreeasily conform to an irregular recipient site.

Embodiments described herein also include a Pixel Skin ResectionProcedure, also referred to herein as the Pixel Procedure. For manypatients who have age related skin laxity (neck and face, arms, axillas,thighs, knees, buttocks, abdomen, bra line, ptosis of the breast, etc.),fractional resection of excess skin could replace a significant segmentof plastic surgery with its incumbent scarring. Generally, the PixelProcedure will be performed in an office setting under a localanesthetic. The post procedure recovery period includes wearing of asupport garment over the treatment area for a pre-specified number(e.g., five, seven, etc.) of days (e.g., five days, seven days, etc.).Relatively little or no pain is anticipated to be associated with theprocedure. The small (e.g., 1.5 mm) circular skin defects will be closedwith the application of an adherent sheet (e.g., Flexan®). Functioningas a large butterfly bandage, the adherent sheet is pulled in adirection (“vector”) that maximizes the aesthetic contouring of thetreatment area. A compressive elastic garment is then applied over thedressing to further assist aesthetic contouring. After completion of theinitial healing phase, the multiplicity of small linear scars within thetreatment area will not be visibly apparent. Furthermore, additionalskin tightening will subsequently occur over several months due to thedelayed wound healing response. Consequently, the Pixel Procedure is aminimally invasive alternative to the extensive scarring of PlasticSurgery.

The pixel array medical devices of an embodiment include a PAD Kit. FIG.1 shows the PAD Kit placed at a target site, under an embodiment. ThePAD Kit comprises a flat perforated guide plate (guide plate), a scalpetpunch or device that includes a scalpet array (FIGS. 1-3), a backedadhesive membrane or adherent substrate (FIG. 4), and a skin pixeltransection blade (FIG. 5), but is not so limited. The scalpet punch ofan embodiment is a handheld device but is not so limited. The guideplate is optional in an alternative embodiment, as described in detailherein.

FIG. 2 is a cross-section of a PAD Kit scalpet punch including a scalpetarray, under an embodiment. The scalpet array includes one or morescalpets. FIG. 3 is a partial cross-section of a PAD Kit scalpet punchincluding a scalpet array, under an embodiment. The partialcross-section shows the total length of the scalpets of the scalpetarray is determined by the thickness of the perforated guide plate andthe incisional depth into the skin, but the embodiment is not solimited.

FIG. 4 shows the adhesive membrane with backing (adherent substrate)included in a PAD Kit, under an embodiment. The undersurface of theadhesive membrane is applied to the incised skin at the target site.

FIG. 5 shows the adhesive membrane (adherent substrate) when used withthe PAD Kit frame and blade assembly, under an embodiment. The topsurface of the adhesive membrane is oriented with the adhesive side downinside the frame and then pressed over the perforated plate to capturethe extruded skin pixels, also referred to herein as plugs or skinplugs.

With reference to FIG. 1, the perforated guide plate is applied to theskin resection/donor site during a procedure using the PAD Kit. Thescalpet punch is applied through at least a set of perforations of theperforated guide plate to incise the skin pixels. The scalpet punch isapplied numerous times to a number of sets of perforations when thescalpet array of the punch includes fewer scalpets then the total numberof perforations of the guide plate. Following one or more serialapplications with the scalpet punch, the incised skin pixels or plugsare captured onto the adherent substrate. The adherent substrate is thenapplied in a manner so the adhesive captures the extruded skin pixels orplugs. As an example, the top surface of the adherent substrate of anembodiment is oriented with the adhesive side down inside the frame(when the frame is used) and then pressed over the perforated plate tocapture the extruded skin pixels or plugs. As the membrane is pulled up,the captured skin pixels are transected at their base by the transectionblade.

FIG. 6 shows the removal of skin pixels, under an embodiment. Theadherent substrate is pulled up and back (away) from the target site,and this act lifts or pulls the incised skin pixels or plugs. As theadherent substrate is being pulled up, the transection blade is used totransect the bases of the incised skin pixels. FIG. 7 is a side view ofblade transection and removal of incised skin pixels with the PAD Kit,under an embodiment. Pixel harvesting is completed with the transectionof the base of the skin pixels or plugs. FIG. 8 is an isometric view ofblade/pixel interaction during a procedure using the PAD Kit, under anembodiment. FIG. 9 is another view during a procedure using the PAD Kit(blade removed for clarity) showing both harvested skin pixels or plugstransected and captured and non-transected skin pixels or plugs prior totransection, under an embodiment. At the donor site, the pixelated skinresection sites are closed with the application of Flexan® sheeting.

The guide plate and scalpet device are also used to generate skindefects at the recipient site. The skin defects are configured toreceive the skin pixels harvested or captured at the donor site. Theguide plate used at the recipient site can be the same guide plate usedat the donor site, or can be different with a different pattern orconfiguration of perforations.

The skin pixels or plugs deposited onto the adherent substrate duringthe transection can next be transferred to the skin defect site(recipient site) where they are applied as a pixelated skin graft at arecipient skin defect site. The adherent substrate has an elastic recoilproperty that enables closer alignment of the skin pixels or plugswithin the skin graft. The incised skin pixels can be applied from theadherent substrate directly to the skin defects at the recipient site.Application of the incised skin pixels at the recipient site includesaligning the incised skin pixels with the skin defects, and insertingthe incised skin pixels into corresponding skin defects at the recipientsite.

The pixel array medical devices of an embodiment include a Pixel ArrayDermatome (PAD). The PAD comprises a flat array of relatively smallcircular scalpets that are secured onto a substrate (e.g., investingplate), and the scalpets in combination with the substrate are referredto herein as a scalpet array, pixel array, or scalpet plate. FIG. 10A isa side view of a portion of the pixel array showing scalpets securedonto an investing plate, under an embodiment. FIG. 10B is a side view ofa portion of the pixel array showing scalpets secured onto an investingplate, under an alternative embodiment. FIG. 10C is a top view of thescalpet plate, under an embodiment. FIG. 10D is a close view of aportion of the scalpet plate, under an embodiment. The scalpet plate isapplied directly to the skin surface. One or more scalpets of thescalpet array include one or more of a pointed surface, a needle, and aneedle including multiple points.

Embodiments of the pixel array medical devices and methods include useof a harvest pattern instead of the guide plate. The harvest patterncomprises indicators or markers on a skin surface on at least one of thedonor site and the recipient site, but is not so limited. The markersinclude any compound that may be applied directly to the skin to mark anarea of the skin. The harvest pattern is positioned at a donor site, andthe scalpet array of the device is aligned with or according to theharvest pattern at the donor site. The skin pixels are incised at thedonor site with the scalpet array as described herein. The recipientsite is prepared by positioning the harvest pattern at the recipientsite. The harvest pattern used at the recipient site can be the sameharvest pattern used at the donor site, or can be different with adifferent pattern or configuration of markers. The skin defects aregenerated, and the incised skin pixels are applied at the recipient siteas described herein. Alternatively, the guide plate of an embodiment isused in applying the harvest pattern, but the embodiment is not solimited.

To leverage established surgical instrumentation, the array of anembodiment is used in conjunction with or as a modification to a drumdermatome, for example a Padget dermatome or a Reese dermatome, but isnot so limited. The Padget drum dermatome referenced herein wasoriginally developed by Dr. Earl Padget in the 1930s, and continues tobe widely utilized for skin grafting by plastic surgeons throughout theworld. The Reese modification of the Padget dermatome was subsequentlydeveloped to better calibrate the thickness of the harvested skin graft.The drum dermatome of an embodiment is a single use (per procedure)disposable, but is not so limited.

Generally, FIG. 11A shows an example of a rolling pixel drum 100, underan embodiment. FIG. 11B shows an example of a rolling pixel drum 100assembled on a handle, under an embodiment. More specifically, FIG. 11Cdepicts a drum dermatome for use with the scalpet plate, under anembodiment.

Generally, as with all pixel devices described herein, the geometry ofthe pixel drum 100 can be a variety of shapes without limitation e.g.,circular, semicircular, elliptical, square, flat, or rectangular. Insome embodiments, the pixel drum 100 is supported by an axel/handleassembly 102 and rotated around a drum rotational component 104 poweredby, e.g., an electric motor. In some embodiments, the pixel drum 100 canbe placed on stand (not shown) when not in use, wherein the stand canalso function as a battery recharger for the powered rotationalcomponent of the drum or the powered component of the syringe plunger.In some embodiments, a vacuum (not shown) can be applied to the skinsurface of the pixel drum 100 and outriggers (not shown) can be deployedfor tracking and stability of the pixel drum 100.

In some embodiments, the pixel drum 100 incorporates an array ofscalpets 106 on the surface of the drum 100 to create small multiple(e.g., 0.5-1.5 mm) circular incisions referred to herein as skin plugs.In some embodiments, the border geometry of the scalpets can be designedto reduce pin cushioning (“trap door”) while creating the skin plugs.The perimeter of each skin plug can also be lengthened by the scalpetsto, for a non-limiting example, a, semicircular, elliptical, orsquare-shaped skin plug instead of a circular-shaped skin plug. In someembodiments, the length of the scalpets 106 may vary depending upon thethickness of the skin area selected by the surgeon for skin graftingpurposes, i.e., partial thickness or full thickness.

When the drum 100 is applied to a skin surface, a blade 108 placedinternal of the drum 100 transects the base of each skin plug created bythe array of scalpets, wherein the internal blade 108 is connected tothe central drum axel/handle assembly 102 and/or connected to outriggersattached to the central axel assembly 102. In some alternativeembodiments, the internal blade 108 is not connected to the drum axelassembly 102 where the base of the incisions of skin is transected. Insome embodiments, the internal blade 108 of the pixel drum 100 mayoscillate either manually or be powered by an electric motor. Dependingupon the density of the circular scalpets on the drum, a variablepercentage of skin (e.g., 20%, 30%, 40%, etc.) can be transected withinan area of excessive skin laxity.

In some embodiments, an added pixel drum harvester 112 is placed insidethe drum 100 to perform a skin grafting operation by harvesting andaligning the transected/pixilated skin incisions/plugs (pixel graft)from tissue of a pixel donor onto an adherent membrane 110 lined in theinterior of the pixel drum 100. A narrow space is created between thearray of scalpets 106 and the adherent membrane 110 for the internalblade 108.

In an embodiment, the blade 108 is placed external to the drum 100 andthe scalpet array 106 where the base of the incised circular skin plugsis transected. In another embodiment, the external blade 108 isconnected to the drum axel assembly 102 when the base of the incisionsof skin is transected. In an alternative embodiment, the external blade108 is not connected to the drum axel assembly 102 when the base of theincisions of skin is transected. The adherent membrane 110 that extractsand aligns the transected skin segments is subsequently placed over askin defect site of a patient. The blade 108 (either internal orexternal) can be a fenestrated layer of blade aligned to the scalpetarray 106, but is not so limited.

The conformable adherent membrane 110 of an embodiment can besemi-porous to allow for drainage at a recipient skin defect when themembrane with the aligned transected skin segments is extracted from thedrum and applied as a skin graft. The adherent semi-porous drum membrane110 can also have an elastic recoil property to bring thetransected/pixilated skin plugs together for grafting onto the skindefect site of the recipient, i.e., the margins of each skin plug can bebrought closer together as a more uniform sheet after the adherentmembrane with pixilated grafts extracted from the drum 100.Alternatively, the adherent semi-porous drum membrane 110 can beexpandable to cover a large surface area of the skin defect site of therecipient. In some embodiments, a sheet of adhesive backer 111 can beapplied between the adherent membrane 110 and the drum harvester 112.The drum array of scalpets 106, blade 108, and adherent membrane 110 canbe assembled together as a sleeve onto a preexisting drum 100, asdescribed in detail herein.

The internal drum harvester 112 of the pixel drum 110 of an embodimentis disposable and replaceable. Limit and/or control the use of thedisposable components can be accomplished by means that includes but isnot limited to electronic, EPROM, mechanical, durability. The electronicand/or mechanical records and/or limits of number of drum rotations forthe disposable drum as well as the time of use for the disposable drumcan be recorded, controlled and/or limited either electronically ormechanically.

During the harvesting portion of the procedure with a drum dermatome,the PAD scalpet array is applied directly to the skin surface. Tocircumferentially incise the skin pixels, the drum dermatome ispositioned over the scalpet array to apply a load onto the subjacentskin surface. With a continuing load, the incised skin pixels areextruded through the holes of the scalpet array and captured onto anadherent membrane on the drum dermatome. The cutting outrigger blade ofthe dermatome (positioned over the scalpet array) transects the base ofextruded skin pixels. The membrane and the pixelated skin composite arethen removed from the dermatome drum, to be directly applied to therecipient skin defect as a skin graft.

With reference to FIG. 11C, an embodiment includes a drum dermatome foruse with the scalpet plate, as described herein. More particularly, FIG.12A shows the drum dermatome positioned over the scalpet plate, under anembodiment. FIG. 12B is an alternative view of the drum dermatomepositioned over the scalpet plate, under an embodiment. The cuttingoutrigger blade of the drum dermatome is positioned on top of thescalpet array where the extruded skin plugs will be transected at theirbase.

FIG. 13A is an isometric view of application of the drum dermatome(e.g., Padgett dermatome) over the scalpet plate, where the adhesivemembrane is applied to the drum of the dermatome before rolling it overthe investing plate, under an embodiment. FIG. 13B is a side view of aportion of the drum dermatome showing a blade position relative to thescalpet plate, under an embodiment. FIG. 13C is a side view of theportion of the drum dermatome showing a different blade positionrelative to the scalpet plate, under an embodiment. FIG. 13D is a sideview of the drum dermatome with another blade position relative to thescalpet plate, under an embodiment. FIG. 13E is a side view of the drumdermatome with the transection blade clip showing transection of skinpixels by the blade clip, under an embodiment. FIG. 13F is a bottom viewof the drum dermatome along with the scalpet plate, under an embodiment.FIG. 13G is a front view of the drum dermatome along with the scalpetplate, under an embodiment. FIG. 13H is a back view of the drumdermatome along with the scalpet plate, under an embodiment.

Depending upon the clinical application, the disposable adherentmembrane of the drum dermatome can be used to deposit/dispose ofresected lax skin or harvest/align a pixilated skin graft.

Embodiments described herein also include a Pixel Onlay Sleeve (POS) foruse with the dermatomes, for example the Padget dermatomes and Reesedermatomes. FIG. 14A shows an assembled view of the dermatome with thePixel Onlay Sleeve (POS), under an embodiment. The POS comprises thedermatome and blade incorporated with an adhesive backer, adhesive, anda scalpet array. The adhesive backer, adhesive, and scalpet array areintegral to the device, but are not so limited. FIG. 14B is an explodedview of the dermatome with the Pixel Onlay Sleeve (POS), under anembodiment. FIG. 14C shows a portion of the dermatome with the PixelOnlay Sleeve (POS), under an embodiment.

The POS, also referred to herein as the “sleeve,” provides a disposabledrum dermatome onlay for the fractional resection of redundant lax skinand the fractional skin grafting of skin defects. The onlay sleeve isused in conjunction with either the Padget and Reese dermatomes as asingle use disposable component. The POS of an embodiment is athree-sided slip-on disposable sleeve that slips onto a drum dermatome.The device comprises an adherent membrane and a scalpet drum array withan internal transection blade. The transection blade of an embodimentincludes a single-sided cutting surface that sweeps across the internalsurface of the scalpet drum array.

In an alternative blade embodiment, a fenestrated cutting layer coversthe internal surface of the scalpet array. Each fenestration with itscutting surface is aligned with each individual scalpet. Instead ofsweeping motion to transect the base of the skin plugs, the fenestratedcutting layer oscillates over the scalpet drum array. A narrow spacebetween the adherent membrane and the scalpet array is created forexcursion of the blade. For multiple harvesting during a skin graftingprocedure, an insertion slot for additional adherent membranes isprovided. The protective layer over the adherent membrane is pealed awayinsitu with an elongated extraction tab that is pulled from anextraction slot on the opposite side of the sleeve assembly. As withother pixel device embodiments, the adherent membrane is semi-porous fordrainage at the recipient skin defect site. To morph the pixilated skingraft into a more continuous sheet, the membrane may also have anelastic recoil property to provide closer alignment of the skin plugswithin the skin graft.

Embodiments described herein include a Slip-On PAD that is configured asa single-use disposable device with either the Padgett or Reesedermatomes. FIG. 15A shows the Slip-On PAD being slid onto a PadgettDrum Dermatome, under an embodiment. FIG. 15B shows an assembled view ofthe Slip-On PAD installed over the Padgett Drum Dermatome, under anembodiment.

The Slip-on PAD of an embodiment is used (optionally) in combinationwith a perforated guide plate. FIG. 16A shows the Slip-On PAD installedover a Padgett Drum Dermatome and used with a perforated template orguide plate, under an embodiment. The perforated guide plate is placedover the target skin site and held in place with adhesive on the bottomsurface of the apron to maintain orientation. The Padgett Dermatome withSlip-On PAD is rolled over the perforated guide plate on the skin.

FIG. 16B shows skin pixel harvesting with a Padgett Drum Dermatome andinstalled Slip-On PAD, under an embodiment. For skin pixel harvesting,the Slip-On PAD is removed, adhesive tape is applied over the drum ofthe Padgett dermatome, and the clip-on blade is installed on theoutrigger arm of the dermatome, which then is used to transect the baseof the skin pixels. The Slip-on PAD of an embodiment is also used(optionally) with standard surgical instrumentation such as a ribbonretractor to protect the adjacent skin of the donor site.

Embodiments of the pixel instruments described herein include a PixelDrum Dermatome (PD2) that is a single use disposable instrument ordevice. The PD2 comprises a cylinder or rolling/rotating drum coupled toa handle, and the cylinder includes a Scalpet Drum Array. An internalblade is interlocked to the drum axle/handle assembly and/or interlockedto outriggers attached to the central axle. As with the PAD and the POSdescribed herein, small multiple pixilated resections of skin areperformed directly in the region of skin laxity, thereby enhancing skintightening with minimal visible scarring.

FIG. 17A shows an example of a Pixel Drum Dermatome being applied to atarget site of the skin surface, under an embodiment. FIG. 17B shows analternative view of a portion of the Pixel Drum Dermatome being appliedto a target site of the skin surface, under an embodiment.

The PD2 device applies a full rolling/rotating drum to the skin surfacewhere multiple small (e.g., 1.5 mm) circular incisions are created atthe target site with a “Scalpet Drum Array”. The base of each skin plugis then transected with an internal blade that is interlocked to thecentral drum axel/handle assembly and/or interlocked to outriggersattached to the central axel. Depending upon the density of the circularscalpets on the drum, a variable percentage of skin can be resected. ThePD2 enables portions (e.g., 20%, 30%, 40%, etc.) of the skin's surfacearea to be resected without visible scarring in an area of excessiveskin laxity, but the embodiment is not so limited.

Another alternative embodiment of the pixel instruments presented hereinis the Pixel Drum Harvester (PDH). Similar to the Pixel Drum Dermatome,an added internal drum harvests and aligns the pixilated resections ofskin onto an adherent membrane that is then placed over a recipient skindefect site of the patient. The conformable adherent membrane issemi-porous to allow for drainage at a recipient skin defect when themembrane with the aligned resected skin segments is extracted from thedrum and applied as a skin graft. An elastic recoil property of themembrane allows closer approximation of the pixilated skin segments,partially converting the pixilated skin graft to a sheet graft at therecipient site.

The pixel array medical systems, instruments or devices, and methodsdescribed herein evoke or enable cellular and/or extracellular responsesthat are obligatory to the clinical outcomes achieved. For the pixeldermatomes, a physical reduction of the skin surface area occurs due tothe pixilated resection of skin, i.e., creation of the skin plugs. Inaddition, a subsequent tightening of the skin results due to the delayedwound healing response. Each pixilated resection initiates an obligatewound healing sequence in multiple phases as described in detail herein.

The first phase of this sequence is the inflammatory phase in whichdegranulation of mast cells release histamine into the “wound”.Histamine release may evoke dilatation of the capillary bed and increasevessel permeability into the extracellular space. This initial woundhealing response occurs within the first day and will be evident aserythema on the skin's surface.

The second phase (of Fibroplasia) commences within three to four days of“wounding”. During this phase, there is migration and mitoticmultiplication of fibroblasts. Fibroplasia of the wound includes thedeposition of neocollagen and the myofibroblastic contraction of thewound.

Histologically, the deposition of neocollagen can be identifiedmicroscopically as compaction and thickening of the dermis. Althoughthis is a static process, the tensile strength of the woundsignificantly increases. The other feature of Fibroplasia is a dynamicphysical process that results in a multi-dimensional contraction of thewound. This component feature of Fibroplasia is due to the activecellular contraction of myofibroblasts. Morphologically, myoblasticcontraction of the wound will be visualized as a two dimensionaltightening of the skin surface. Overall, the effect of Fibroplasia isdermal contraction along with the deposition of a static supportingscaffolding of neocollagen with a tightened framework. The clinicaleffect is seen as a delayed tightening of skin with smoothing of skintexture over several months. The clinical endpoint is generally a moreyouthful appearing skin envelope of the treatment area.

A third and final phase of the delayed wound healing response ismaturation. During this phase there is a strengthening and remodeling ofthe treatment area due to an increased cross-linkage of the collagenfibril matrix (of the dermis). This final stage commences within six totwelve months after “wounding” and may extend for at least one to twoyears. Small pixilated resections of skin should preserve the normaldermal architecture during this delayed wound healing process withoutthe creation of an evident scar that typically occurs with a largersurgical resection of skin. Lastly, there is a related stimulation andrejuvenation of the epidermis from the release of epidermal growthhormone. The delayed wound healing response can be evoked, with scarcollagen deposition, within tissues (such as muscle or fat) with minimalpre-existing collagen matrix.

Other than tightening skin for aesthetic purposes, the pixel arraymedical systems, instruments or devices, and methods described hereinmay have additional medically related applications. In some embodiments,the pixel array devices can transect a variable portion of any softtissue structure without resorting to a standard surgical resection.More specifically, the reduction of an actinic damaged area of skin viathe pixel array devices should reduce the incidence of skin cancer. Forthe treatment of sleep apnea and snoring, a pixilated mucosal reduction(soft palate, base of the tongue and lateral pharyngeal walls) via thepixel array devices would reduce the significant morbidity associatedwith more standard surgical procedures. For birth injuries of thevaginal vault, pixilated skin and vaginal mucosal resection via thepixel array devices would reestablish normal pre-partum geometry andfunction without resorting to an A&P resection. Related female stressincontinence could also be corrected in a similar fashion.

The pixel array dermatome (PAD) of an embodiment, also referred toherein as a scalpet device assembly, includes a system or kit comprisinga control device, also referred to as a punch impact hand-piece, and ascalpet device, also referred to as a tip device. The scalpet device,which is removeably coupled to the control device, includes an array ofscalpets positioned within the scalpet device. The removeable scalpetdevice of an embodiment is disposable and consequently configured foruse during a single procedure, but the embodiment is not so limited.

The PAD includes an apparatus comprising a housing configured to includea scalpet device. The scalpet device includes a substrate and a scalpetarray, and the scalpet array includes a plurality of scalpets arrangedin a configuration on the substrate. The substrate and the plurality ofscalpets are configured to be deployed from the housing and retractedinto the housing, and the plurality of scalpets is configured togenerate a plurality of incised skin pixels at a target site whendeployed. The proximal end of the control device is configured to behand-held. The housing is configured to be removeably coupled to areceiver that is a component of a control device. The control deviceincludes a proximal end that includes an actuator mechanism, and adistal end that includes the receiver. The control device is configuredto be disposable, but alternatively the control device is configured tobe at least one of cleaned, disinfected, and sterilized.

The scalpet array is configured to be deployed in response to activationof the actuator mechanism. The scalpet device of an embodiment isconfigured so the scalpet array is deployed from the scalpet device andretracted back into the scalpet device in response to activation of theactuator mechanism. The scalpet device of an alternative embodiment isconfigured so the scalpet array is deployed from the scalpet device inresponse to activation of the actuator mechanism, and retracted backinto the scalpet device in response to release of the actuatormechanism.

FIG. 18 shows a side perspective view of the PAD assembly, under anembodiment. The PAD assembly of this embodiment includes a controldevice configured to be hand-held, with an actuator or trigger and thescalpet device comprising the scalpet array. The control device isreusable, but alternative embodiments include a disposable controldevice. The scalpet array of an embodiment is configured to create orgenerate an array of incisions (e.g., 1.5 mm, 2 mm, 3 mm, etc.) asdescribed in detail herein. The scalpet device of an embodiment includesa spring-loaded array of scalpets configured to incise the skin asdescribed in detail herein, but the embodiments are not so limited.

FIG. 19A shows a top perspective view of the scalpet device for use withthe PAD assembly, under an embodiment. FIG. 19B shows a bottomperspective view of the scalpet device for use with the PAD assembly,under an embodiment. The scalpet device comprises a housing configuredto house a substrate that is coupled to or includes a plunger. Thehousing is configured so that a proximal end of the plunger protrudesthrough a top surface of the housing. The housing is configured to beremoveably coupled to the control device, and a length of the plunger isconfigured to protrude a distance through the top surface to contact thecontrol device and actuator when the scalpet device is coupled to thecontrol device.

The substrate of the scalpet device is configured to retain numerousscalpets that form the scalpet array. The scalpet array comprises apre-specified number of scalpets as appropriate to the procedure inwhich the scalpet device assembly is used. The scalpet device includesat least one spring mechanism configured to provide a downward, orimpact or punching, force in response to activation of the scalpet arraydevice, and this force assists generation of incisions (pixelated skinresection sites) by the scalpet array. Alternatively, the springmechanism can be configured to provide an upward, or retracting, forceto assist in retraction of the scalpet array.

One or more of the scalpet device and the control device of anembodiment includes an encryption system (e.g., EPROM, etc.). Theencryption system is configured to prevent illicit use and pirating ofthe scalpet devices and/or control devices, but is not so limited.

During a procedure, the scalpet device assembly is applied one time to atarget area or, alternative, applied serially within a designated targettreatment area of skin laxity. The pixelated skin resection sites withinthe treatment area are then closed with the application of Flexansheeting, as described in detail herein, and directed closure of thesepixelated resections is performed in a direction that provides thegreatest aesthetic correction of the treatment site.

The PAD device of an alternative embodiment includes a vacuum componentor system for removing incised skin pixels. FIG. 20 shows a side view ofthe punch impact device including a vacuum component, under anembodiment. The PAD of this example includes a vacuum system orcomponent within the control device to suction evacuate the incised skinpixels, but is not so limited. The vacuum component is removeablycoupled to the PAD device, and its use is optional. The vacuum componentis coupled to and configured to generate a low-pressure zone within oradjacent to one or more of the housing, the scalpet device, the scalpetarray, and the control device. The low-pressure zone is configured toevacuate the incised skin pixels.

The PAD device of another alternative embodiment includes a radiofrequency (RF) component or system for generating skin pixels. The RFcomponent is coupled to and configured to provide or couple energywithin or adjacent to one or more of the housing, the scalpet device,the scalpet array, and the control device. The RF component isremoveably coupled to the PAD device, and its use is optional. Theenergy provided by the RF component includes one or more of thermalenergy, vibrational energy, rotational energy, and acoustic energy, toname a few.

The PAD device of yet another alternative embodiment includes a vacuumcomponent or system and an RF component or system. The PAD of thisembodiment includes a vacuum system or component within the handpiece tosuction evacuate the incised skin pixels. The vacuum component isremoveably coupled to the PAD device, and its use is optional. Thevacuum component is coupled to and configured to generate a low-pressurezone within or adjacent to one or more of the housing, the scalpetdevice, the scalpet array, and the control device. The low-pressure zoneis configured to evacuate the incised skin pixels. Additionally, the PADdevice includes an RF component coupled to and configured to provide orcouple energy within or adjacent to one or more of the housing, thescalpet device, the scalpet array, and the control device. The RFcomponent is removeably coupled to the PAD device, and its use isoptional. The energy provided by the RF component includes one or moreof thermal energy, vibrational energy, rotational energy, and acousticenergy, to name a few.

As one particular example, the PAD of an embodiment includes anelectrosurgical generator configured to more effectively incise donorskin or skin plugs with minimal thermo-conductive damage to the adjacentskin. For this reason, the RF generator operates using relatively highpower levels with relatively short duty cycles, for example. The RFgenerator is configured to supply one or more of a powered impactorcomponent configured to provide additional compressive force forcutting, cycling impactors, vibratory impactors, and an ultrasonictransducer.

The PAD with RF of this example also includes a vacuum component, asdescribed herein. The vacuum component of this embodiment is configuredto apply a vacuum that pulls the skin up towards the scalpets (e.g.,into the lumen of the scalpets, etc.) to stabilize and promote the RFmediated incision of the skin within the fractional resection field, butis not so limited. One or more of the RF generator and the vacuumappliance is coupled to be under the control of a processor running asoftware application. Additionally, the PAD of this embodiment can beused with the guide plate as described in detail herein, but is not solimited.

In addition to fractional incision at a donor site, fractional skingrafting includes the harvesting and deposition of skin plugs (e.g.,onto an adherent membrane, etc.) for transfer to a recipient site. Aswith fractional skin resection, the use of a duty-driven RF cutting edgeon an array of scalpets facilitates incising donor skin plugs. The baseof the incised scalpets is then transected and harvested as described indetail herein.

The timing of the vacuum assisted component is processor controlled toprovide a prescribed sequence with the RF duty cycle. With softwarecontrol, different variations are possible to provide the optimalsequence of combined RF cutting with vacuum assistance. Withoutlimitation, these include an initial period of vacuum prior to the RFduty cycle. Subsequent to the RF duty cycle, a period during thesequence of an embodiment includes suction evacuation of the incisedskin plugs.

Other potential control sequences of the PAD include without limitationsimultaneous duty cycles of RF and vacuum assistance. Alternatively, acontrol sequence of an embodiment includes pulsing or cycling of the RFduty cycle within the sequence and/or with variations of RF power or theuse of generators at different RF frequencies.

Another alternative control sequence includes a designated RF cycleoccurring at the depth of the fractional incision. A lower power longerduration RF duty cycle with insulated shaft with an insulated shaft anactive cutting tip could generate a thermal-conductive lesion in thedeep dermal/subcutaneous tissue interface. The deep thermal lesion wouldevoke a delayed wound healing sequence that would secondarily tightenthe skin without burning of the skin surface.

With software control, different variations are possible to provide theoptimal sequence of combined RF cutting and powered mechanical cuttingwith vacuum assistance. Examples include but are not limited tocombinations of powered mechanical cutting with vacuum assistance, RFcutting with powered mechanical cutting and vacuum assistance, RFcutting with vacuum assistance, and RF cutting with vacuum assistance.Examples of combined software controlled duty cycles include but are notlimited to precutting vacuum skin stabilization period, RF cutting dutycycle with vacuum skin stabilization period, RF cutting duty cycle withvacuum skin stabilization and powered mechanical cutting period, poweredmechanical cutting with vacuum skin stabilization period, post cuttingRF duty cycle for thermal conductive heating of the deeper dermal and/orsubdermal tissue layer to evoke a wound healing response for skintightening, and a post cutting vacuum evacuation period for skintightening.

Another embodiment of pixel array medical devices described hereinincludes a device comprising an oscillating flat array of scalpets andblade either powered electrically or deployed manually (unpowered) andused for skin tightening as an alternative to the drum/cylinderdescribed herein. FIG. 21A shows a top view of an oscillating flatscalpet array and blade device, under an embodiment. FIG. 21B shows abottom view of an oscillating flat scalpet array and blade device, underan embodiment. Blade 108 can be a fenestrated layer of blade aligned tothe scalpet array 106. The instrument handle 102 is separated from theblade handle 103 and the adherent membrane 110 can be peeled away fromthe adhesive backer 111. FIG. 21C is a close-up view of the flat arraywhen the array of scalpets 106, blades 108, adherent membrane 110 andthe adhesive backer 111 are assembled together, under an embodiment. Asassembled, the flat array of scalpets can be metered to provide auniform harvest or a uniform resection. In some embodiments, the flatarray of scalpets may further include a feeder component 115 for theadherent harvesting membrane 110 and adhesive backer 111. FIG. 21D is aclose-up view of the flat array of scalpets with a feeder component 115,under an embodiment.

In another skin grafting embodiment, the pixel graft is placed onto anirradiated cadaver dermal matrix (not shown). When cultured onto thedermal matrix, a graft of full thickness skin is created for the patientthat is immunologically identical to the pixel donor. In embodiments,the cadaver dermal matrix can also be cylindrical transected similar insize to the harvested skin pixel grafts to provide histologicalalignment of the pixilated graft into the cadaver dermal framework. FIG.22 shows a cadaver dermal matrix cylindrically transected similar insize to the harvested skin pixel grafts, under an embodiment. In someembodiments, the percentage of harvest of the donor site can bedetermined in part by the induction of a normal dermal histology at theskin defect site of the recipient, i.e., a normal (smoother) surfacetopology of the skin graft is facilitated. With either the adherentmembrane or the dermal matrix embodiment, the pixel drum harvesterincludes the ability to harvest a large surface area for grafting withvisible scarring of the patient's donor site significantly reduced oreliminated.

In addition to the pixel array medical devices described herein,embodiments include drug delivery devices. For the most part, theparenteral delivery of drugs is still accomplished from an injectionwith a syringe and needle. To circumvent the negative features of theneedle and syringe system, the topical absorption of medicationtranscutaneously through an occlusive patch was developed. However, bothof these drug delivery systems have significant drawbacks. The humanaversion to a needle injection has not abated during the nearly twocenturies of its use. The variable systemic absorption of either asubcutaneous or intramuscular drug injection reduces drug efficacy andmay increase the incidence of adverse patient responses. Depending uponthe lipid or aqueous carrier fluid of the drug, the topically appliedocclusive patch is plagued with variable absorption across an epidermalbarrier. For patients who require local anesthesia over a large surfacearea of skin, neither the syringe/needle injections nor topicalanesthetics are ideal. The syringe/needle “field” injections are oftenpainful and may instill excessive amounts of the local anesthetic thatmay cause systemic toxicity. Topical anesthetics rarely provide thelevel of anesthesia required for skin related procedures.

FIG. 23 is a drum array drug delivery device 200, under an embodiment.The drug delivery device 200 successfully addresses the limitations anddrawbacks of other drug delivery systems. The device comprises adrum/cylinder 202 supported by an axel/handle assembly 204 and rotatedaround a drum rotation component 206. The handle assembly 204 of anembodiment further includes a reservoir 208 of drugs to be delivered anda syringe plunger 210. The surface of the drum 202 is covered by anarray of needles 212 of uniform length, which provide a uniformintradermal (or subdermal) injection depth with a more controlled volumeof the drug injected into the skin of the patient. During operation, thesyringe plunger 210 pushes the drug out of the reservoir 208 to beinjected into a sealed injection chamber 214 inside the drum 202 viaconnecting tube 216. The drug is eventually delivered into the patient'sskin at a uniform depth when the array of needles 212 is pushed into apatient's skin until the surface of the drum 202 hits the skin.Non-anesthetized skip area is avoided and a more uniform pattern ofcutaneous anesthesia is created. The rolling drum application of thedrug delivery device 200 also instills the local anesthetic faster withless discomfort to the patient.

FIG. 24A is a side view of a needle array drug delivery device 300,under an embodiment. FIG. 24B is an upper isometric view of a needlearray drug delivery device 300, under an embodiment. FIG. 24C is a lowerisometric view of a needle array drug delivery device 300, under anembodiment. The drug delivery device 300 comprises a flat array of fineneedles 312 of uniform length positioned on manifold 310 can be utilizedfor drug delivery. In this example embodiment, syringe 302 in which drugfor injection is contained can be plugged into a disposable adaptor 306with handles, and a seal 308 can be utilized to ensure that the syringe302 and the disposable adaptor 306 are securely coupled to each other.When the syringe plunger 304 is pushed, drug contained in syringe 302 isdelivered from syringe 302 into the disposable adaptor 306. The drug isfurther delivered into the patient's skin through the flat array of fineneedles 312 at a uniform depth when the array of needles 312 is pushedinto a patient's skin until manifold 310 hits the skin.

The use of the drug delivery device 200 may have as many clinicalapplications as the number of pharmacological agents that requiretranscutaneous injection or absorption. For non-limiting examples, a fewof the potential applications are the injection of local anesthetics,the injection of neuromodulators such as Botulinum toxin (Botox), theinjection of insulin and the injection of replacement estrogens andcorticosteroids.

In some embodiments, the syringe plunger 210 of the drug delivery device200 can be powered by, for a non-limiting example, an electric motor. Insome embodiments, a fluid pump (not shown) attached to an IV bag andtubing can be connected to the injection chamber 214 and/or thereservoir 208 for continuous injection. In some embodiments, the volumeof the syringe plunger 210 in the drug delivery device 200 is calibratedand programmable.

Another application of pixel skin graft harvesting with the PAD (PixelArray Dermatome) device as described in detail herein is Alopecia.Alopecia is a common aesthetic malady, and it occurs most frequently inthe middle-aged male population, but is also observed in the aging babyboomer female population. The most common form of alopecia is MalePattern Baldness (MPB) that occurs in the frontal-parietal region of thescalp. Male pattern baldness is a sex-linked trait that is transferredby the X chromosome from the mother to male offspring. For men, only onegene is needed to express this phenotype. As the gene is recessive,female pattern baldness requires the transfer of both X linked genesfrom both mother and father. Phenotypic penetrance can vary from patientto patient and is most frequently expressed in the age of onset and theamount of frontal/partial/occipital alopecia. The patient variability inthe phenotypic expression of MPB is due to the variable genotypictranslation of this sex-linked trait. Based upon the genotypicoccurrence of MPB, the need for hair transplantation is vast. Othernon-genetic related etiologies are seen in a more limited segment of thepopulation. These non-genetic etiologies include trauma, fungalinfections, lupus erythematosus, radiation and chemotherapy.

A large variety of treatment options have been proposed to the public.These include FDA approved topical medications such as Minoxidil andFinasteride which have had limited success as these agents require theconversion of dormant hair follicles into an anagen growth phase. Otherremedies include hairpieces and hair weaving. The standard of practiceremains surgical hair transplantation, which involves the transfer ofhair plugs, strips and flaps from the hair-bearing scalp into the nonhair-bearing scalp. For the most part, conventional hair transplantationinvolves the transfer of multiple single hair micrographs from thehair-bearing scalp to the non hair-bearing scalp of the same patient.Alternately, the donor plugs are initially harvested as hair strips andthen secondarily sectioned into micrographs for transfer to therecipient scalp. Regardless, this multi-staged procedure is both tediousand expensive, involving several hours of surgery for the averagepatient.

The conventional hair transplantation market has been encumbered bylengthy hair grafting procedures that are performed in several stages. Atypical hair grafting procedure involves the transfer of hair plugs froma donor site in the occipital scalp to a recipient site in the baldingfrontal-parietal scalp. For most procedures, each hair plug istransferred individually to the recipient scalp. Several hundred plugsmay be transplanted during a procedure that may require several hours toperform. Post procedure “take” or viability of the transplanted hairplugs is variable due to factors that limit neovascularization at therecipient site. Bleeding and mechanical disruption due to motion are keyfactors that reduce neovascularization and “take” of hair grafts.Embodiments described herein include surgical instrumentation configuredto transfer several hair grafts at once that are secured and aligned enmasse at a recipient site on the scalp. The procedures described hereinusing the PAD of an embodiment reduce the tedium and time required withconventional instrumentation.

FIG. 25 shows the composition of human skin. Skin comprises twohorizontally stratified layers, referred to as the epidermis and thedermis, acting as a biological barrier to the external environment. Theepidermis is the enveloping layer and comprises a viable layer ofepidermal cells that migrate upward and “mature” into a non-viable layercalled the stratum corneum. The stratum corneum is a lipid-keratincomposite that serves as a primary biological barrier, and this layer iscontinually shed and reconstituted in a process called desquamation. Thedermis is the subjacent layer that is the main structural support of theskin, and is predominately extracellular and is comprised of collagenfibers.

In addition to the horizontally stratified epidermis and dermis, theskin includes vertically-aligned elements or cellular appendagesincluding the pilosebaceous units, comprising the hair follicle andsebaceous gland. Pilosebaceous units each include a sebaceous oil glandand a hair follicle. The sebaceous gland is the most superficial anddischarges sebum (oil) into the shaft of the hair follicle. The base ofthe hair follicle is called the bulb and the base of the bulb has a deepgenerative component called the dermal papilla. The hair follicles aretypically aligned at an oblique angle to the skin surface. Hairfollicles in a given region of the scalp are aligned parallel to eachother. Although pilosebaceous units are common throughout the entireintegument, the density and activity of these units within a region ofthe scalp is a key determinate as to the overall appearance of hair.

In additional to pilosebaceous units, sweat glands also coursevertically through the skin. They provide a water-based transudate thatassists in thermoregulation. Apocrine sweat glands in the axilla andgroin express a more pungent sweat that is responsible for body odor.For the rest of the body, eccrine sweat glands excrete a less pungentsweat for thermoregulation.

Hair follicles proceed through different physiological cycles of hairgrowth. FIG. 26 shows the physiological cycles of hair growth. Thepresence of testosterone in a genetically-prone man will producealopecia to a variable degree in the frontal-parietal scalp.Essentially, the follicle becomes dormant by entering the telogen phasewithout return to the anagen phase. Male Pattern Baldness occurs whenthe hair fails to return from the telogen phase to the anagen phase.

The PAD of an embodiment is configured for en-masse harvesting ofhair-bearing plugs with en-masse transplantation of hair bearing plugsinto non hair-bearing scalp, which truncates conventional surgicalprocedures of hair transplantation. Generally, the devices, systemsand/or methods of an embodiment are used to harvest and align a largemultiplicity of small hair bearing plugs in a single surgical step orprocess, and the same instrumentation is used to prepare the recipientsite by performing a multiple pixelated resection of non hair-bearingscalp. The multiple hair-plug graft is transferred and transplanteden-masse to the prepared recipient site. Consequently, through use of anabbreviated procedure, hundreds of hair bearing plugs can be transferredfrom a donor site to a recipient site. Hair transplantation using theembodiments described herein therefore provides a solution that is asingle surgical procedure having ease, simplicity and significant timereduction over the tedious and multiple staged conventional process.

Hair transplantation using the pixel dermatome of an embodimentfacilitates improvements in the conventional standard follicular unitextraction (FUT) hair transplant approach. Generally, under theprocedure of an embodiment hair follicles to be harvested are taken fromthe Occipital scalp of the donor. In so doing, the donor site hair ispartially shaved, and the perforated plate of an embodiment is locatedon the scalp and oriented to provide a maximum harvest. FIG. 27 showsharvesting of donor follicles, under an embodiment. The scalpets in thescalpet array are configured to penetrate down to the subcutaneous fatlater to capture the hair follicle. Once the hair plugs are incised,they are harvested onto an adhesive membrane by transecting the base ofthe hair plug with the transection blade, as described in detail herein.Original alignment of the hair plugs with respect to each other at thedonor site is maintained by applying the adherent membrane beforetransecting the base. The aligned matrix of hair plugs on the adherentmembrane will then be grafted en masse to a recipient site on thefrontal-parietal scalp of the recipient.

FIG. 28 shows preparation of the recipient site, under an embodiment.The recipient site is prepared by resection of non-hair bearing skinplugs in a topographically identical pattern as the harvested occipitalscalp donor site. The recipient site is prepared for the mass transplantof the hair plugs using the same instrumentation that was used at thedonor site under an embodiment and, in so doing, scalp defects arecreated at the recipient site. The scalp defects created at therecipient site have the same geometry as the harvested plugs on theadherent membrane.

The adherent membrane laden with the harvested hair plugs is appliedover the same pattern of scalp defects at the recipient site.Row-by-row, each hair-bearing plug is inserted into its mirror imagerecipient defect. FIG. 29 shows placement of the harvested hair plugs atthe recipient site, under an embodiment. Plug-to-plug alignment ismaintained, so the hair that grows from the transplanted hair plugs laysas naturally as it did at the donor site. More uniform alignment betweenthe native scalp and the transplanted hair will also occur.

More particularly, the donor site hair is partially shaved to preparefor location or placement of the perforated plate on the scalp. Theperforated plate is positioned on the occipital scalp donor site toprovide a maximum harvest. FIG. 30 shows placement of the perforatedplate on the occipital scalp donor site, under an embodiment. Massharvesting of hair plugs is achieved using the spring-loaded pixilationdevice comprising the impact punch hand-piece with a scalpet disposabletip. An embodiment is configured for harvesting of individual hair plugsusing off-the-shelf FUE extraction devices or biopsy punches; the holesin the perforated plates supplied are sized to accommodate off-the-shelftechnology.

The scalpets comprising the scalpet array disposable tip are configuredto penetrate down to the subcutaneous fat later to capture the hairfollicle. FIG. 31 shows scalpet penetration depth through skin when thescalpet is configured to penetrate to the subcutaneous fat layer tocapture the hair follicle, under an embodiment. Once the hair plugs areincised, they are harvested onto an adhesive membrane by transecting thebase of the hair plug with the transection blade, but are not solimited. FIG. 32 shows hair plug harvesting using the perforated plateat the occipital donor site, under an embodiment. The original alignmentof the hair plugs with respect to each other is maintained by applyingan adherent membrane of an embodiment. The adherent membrane is appliedbefore transecting the base of the resected pixels, the embodiments arenot so limited. The aligned matrix of hair plugs on the adherentmembrane is subsequently grafted en masse to a recipient site on thefrontal-parietal scalp.

Additional single hair plugs may be harvested through the perforatedplate, to be used to create the visible hairline, for example. FIG. 33shows creation of the visible hairline, under an embodiment. The visiblehairline is determined and developed with a manual FUT technique. Thevisible hairline and the mass transplant of the vertex may be performedconcurrently or as separate stages. If the visible hairline and masstransplant are performed concurrently, the recipient site is developedstarting with the visible hairline.

Transplantation of harvested hair plugs comprises preparing therecipient site is prepared by resecting non-hair bearing skin plugs in atopographically identical pattern as the pattern of the harvestedoccipital scalp donor site. FIG. 34 shows preparation of the donor siteusing the patterned perforated plate and spring-loaded pixilation deviceto create identical skin defects at the recipient site, under anembodiment. The recipient site of an embodiment is prepared for the masstransplant of the hair plugs using the same perforated plate andspring-loaded pixilation device that was used at the donor site. Scalpdefects are created at the recipient site. These scalp defects have thesame geometry as the harvested plugs on the adherent membrane.

The adherent membrane carrying the harvested hair plugs is applied overthe same pattern of scalp defects at recipient site. Row-by-row eachfollicle-bearing or hair-bearing skin plug is inserted into its mirrorimage recipient defect. FIG. 35 shows transplantation of harvested plugsby inserting harvested plugs into a corresponding skin defect created atthe recipient site, under an embodiment. Plug-to-plug alignment ismaintained, so the hair that grows from the transplanted hair plugs laysas naturally as it did at the donor site. More uniform alignment betweenthe native scalp and the transplanted hair will also occur.

Clinical endpoints vary from patient to patient, but it is predictedthat a higher percentage of hair plugs will “take” as a result ofimproved neovascularization. FIG. 36 shows a clinical end point usingthe pixel dermatome instrumentation and procedure, under an embodiment.The combination of better “takes”, shorter procedure times, and a morenatural-looking result, enable the pixel dermatome instrumentation andprocedure of an embodiment to overcome the deficiencies in conventionalhair transplant approaches.

Embodiments of pixelated skin grafting for skin defects and pixelatedskin resection for skin laxity are described in detail herein. Theseembodiments remove a field of skin pixels in an area of lax skin whereskin tightening is desired. The skin defects created by this procedure(e.g., in a range of approximately 1.5-3 mm-diameter) are small enoughto heal per primam without visible scarring; the wound closure of themultiple skin defects is performed directionally to produce a desiredcontouring effect. Live animal testing of the pixel resection procedurehas produced excellent results.

The pixel procedure of an embodiment is performed in an office settingunder a local anesthetic but is not so limited. The surgeon uses theinstrumentation of an embodiment to rapidly resect an array of skinpixels (e.g., circular, elliptical, square, etc.). Relatively littlepain is associated with the procedure. The intradermal skin defectsgenerated during the procedure are closed with the application of anadherent Flexan (3M) sheet, but embodiments are not so limited.Functioning as a large butterfly bandage, the Flexan sheet is pulled ina direction that maximizes the aesthetic contouring of the treatmentarea. A compressive elastic garment is then applied over the dressing toassist aesthetic contouring. During recovery, the patient wears asupport garment over the treatment area for a period of time (e.g., 5days, etc.). After initial healing, the multiplicity of small linearscars within the treatment area is not visibly apparent. Additional skintightening will occur subsequently over several months from the delayedwound healing response. Consequently, the pixel procedure is a minimallyinvasive alternative for skin tightening in areas where the extensivescarring of traditional aesthetic plastic surgery is to be avoided.

The pixel procedure evokes cellular and extracellular responses that areobligatory to the clinical outcomes achieved. A physical reduction ofthe skin surface area occurs due to the fractional resection of skin,which physically removes a portion of skin directly in the area oflaxity. In addition, a subsequent tightening of the skin is realizedfrom the delayed wound healing response. Each pixilated resectioninitiates an obligate wound healing sequence. The healing responseeffected in an embodiment comprises three phases, as previouslydescribed in detail herein.

The first phase of this sequence is the inflammatory phase in whichdegranulation of mast cells releases histamine into the “wound”.Histamine release evokes dilatation of the capillary bed and increasesvessel permeability into the extracellular space. This initial woundhealing response occurs within the first day and will be evident aserythema on the skin's surface.

Within days of “wounding”, the second phase of healing, fibroplasia,commences. During fibroplasia, there is migration and mitoticmultiplication of fibroblasts. Fibroplasia has two key features: thedeposition of neocollagen and the myofibroblastic contraction of thewound. Histologically, the deposition of neocollagen is identifiedmicroscopically as compaction and thickening of the dermis. Althoughthis is a static process, the tensile strength of the skin significantlyincreases. Myofibroblastic contraction is a dynamic physical processthat results in two-dimensional tightening of the skin surface. Thisprocess is due to the active cellular contraction of myofibroblasts andthe deposition of contractile proteins within the extracellular matrix.Overall, the effect of fibroplasia will be dermal contraction and thedeposition of a static supporting scaffolding of neocollagen with atightened framework. The clinical effect is realized as a delayedtightening of skin with smoothing of skin texture over some number ofmonths. The clinical endpoint is a more youthful appearing skin envelopeof the treatment area.

A third and final phase of the delayed wound healing response ismaturation. During maturation, there is a strengthening and remodelingof the treatment area due to increased cross-linkage of the collagenfibril matrix (of the dermis). This final stage commences within 6 to 12months after “wounding” and may extend for at least 1-2 years. Smallpixilated resections of skin should preserve the normal dermalarchitecture during maturation, but without the creation of a visuallyevident scar that typically occurs with a larger surgical resection ofskin. Lastly, there is a related stimulation and rejuvenation of theepidermis from the release of epidermal growth hormone.

FIGS. 37-42 show images resulting from a pixel procedure conducted on alive animal, under an embodiment. Embodiments described herein were usedin this proof-of-concept study in an animal model that verified thepixel procedure produces aesthetic skin tightening without visiblescarring. The study used a live porcine model, anesthetized for theprocedure. FIG. 37 is an image of the skin tattooed at the corners andmidpoints of the area to be resected, under an embodiment. The fieldmargins of resection were demarcated with a tattoo for post-operativeassessment, but embodiments are not so limited. The procedure wasperformed using a perforated plate (e.g., 10×10 pixel array) todesignate the area for fractional resection. The fractional resectionwas performed using biopsy punches (e.g., 1.5 mm diameter). FIG. 38 isan image of the post-operative skin resection field, under anembodiment. Following the pixel resection, the pixelated resectiondefects were closed (horizontally) with a membrane (e.g., Flexan).

Eleven days following the procedure, all resections had healed perprimum in the area designated by the tattoo, and photographic anddimensional measurements were made. FIG. 39 is an image at 11 daysfollowing the procedure showing resections healed per primum, withmeasured margins, under an embodiment. Photographic and dimensionalmeasurements were subsequently made 29 days following the procedure.FIG. 40 is an image at 29 days following the procedure showingresections healed per primum and maturation of the resection fieldcontinuing per primum, with measured margins, under an embodiment. FIG.41 is an image at 29 days following the procedure showing resectionshealed per primum and maturation of the resection field continuing perprimum, with measured lateral dimensions, under an embodiment.Photographic and dimensional measurements were repeated 90 dayspost-operative, and the test area skin was completely smooth to touch.FIG. 42 is an image at 90 days post-operative showing resections healedper primam and maturation of the resection field continuing per primum,with measured lateral dimensions, under an embodiment.

Fractional resection as described herein is performed intradermally orthrough the entire thickness of the dermis. The ability to incise skinwith a scalpet (e.g., round, square, elliptical, etc.) is enhanced withthe addition of additional force(s). The additional force includes forceapplied to the scalpet or scalpet array, for example, where the forcecomprises one or more of rotational force, kinetic impact force, andvibrational force, all of which are described in detail herein for skinfractional resection.

The scalpet device of an embodiment generally includes a scalpetassembly and a housing. The scalpet assembly includes a scalpet array,which comprises a number of scalpets, and force or drive components. Thescalpet assembly includes one or more alignment plates configured toretain and position the scalpets precisely according to theconfiguration of the scalpet array, and to transmit force (e.g., z-axis)from the operator to the subject tissue targeted for resection. Thescalpet assembly includes spacers configured to retain alignment platesat a fixed distance apart and coaxial with the scalpet array, but is notso limited.

A shell is configured to retain the spacers and the alignment plates,and includes attachment point(s) for the housing and drive shaft. Thealignment plates and/or the spacers are attached or connected (e.g.,snapped, welded (e.g., ultrasonic, laser, etc.), heat-staked, etc.) intoposition in the shell, thereby providing a rigid assembly anddiscourages tampering or re-purposing of the scalpet array.Additionally, the shell protects the drive mechanism or gearing andscalpets from contamination during use and allows lubrication (ifrequired) to be applied to the gearing to reduce the torque requirementand increase the life of the gears.

As an example of the application of force using the embodiments herein,the ability to incise skin with a circular scalpet is enhanced with theaddition of a rotational torque. The downward axial force used to incisethe skin is significantly reduced when applied in combination with arotational force. This enhanced capability is similar to a surgeonincising skin with a standard scalpel where the surgeon uses acombination of movement across the skin (kinetic energy) with thesimultaneous application of compression (axial force) to moreeffectively cut the skin surface.

For piercing the skin, the amount of surface compression required issignificantly reduced if a vertical kinetic force is employedsimultaneously. For example, a dart throwing technique for injectionshas previously been used by healthcare providers for piercing skin. An“impactor” action imparted on skin by a circular scalpet of anembodiment enhances this modality's cutting capability by simultaneouslyemploying axial compressive and axial kinetic forces. The axialcompressive force used to incise the skin surface is significantlyreduced if applied in combination with kinetic force.

Conventional biopsy punches are intended for a single use application inthe removal of tissue, which is generally achieved by pushing the punchdirectly into the tissue along its central axis. Similarly, thefractional resection of an embodiment uses scalpets comprising acircular configuration. While the scalpets of an embodiment can be usedin a stand-alone configuration, alternative embodiments include scalpetarrays in which scalpets are bundled together in arrays of various sizesconfigured to remove sections of skin, but are not so limited. The forceused to pierce the skin using the fractional resection scalpet is afunction of the number of scalpets in the array, so that as the arraysize increases the force used to pierce the skin increases.

The ability to incise skin with a circular scalpet is significantlyenhanced with a reduction in the force needed to pierce the skinintroduced through the addition of a rotational motion around itscentral axis and/or an impact force along its central axis. FIG. 43 is ascalpet showing the applied rotational and/or impact forces, under anembodiment. This enhanced rotational configuration has an affect similarto a surgeon incising skin with a standard scalpel where the surgeonuses a combination of movement across the skin (kinetic energy) with thesimultaneous application of compression (axial force) to moreeffectively cut the skin surface. The impact force is similar to the useof a staple gun or by quickly moving a hypodermic needle prior toimpacting the skin.

A consideration in the configuration of the scalpet rotation is theamount of torque used to drive multiple scalpets at a preferred speed,because the physical size and power of the system used to drive thescalpet array increases as the required torque increases. To reduce theincisional force required in a scalpet array, rows or columns orsegments of the array may be individually driven or sequentially drivenduring an array application. Approaches for rotating the scalpetsinclude but are not limited to geared, helical, slotted, inner helical,pin driven, and frictional (elastomeric).

The scalpet array configured for fractional resection using combinedrotation and axial incision uses one or more device configurations forrotation. For example, the scalpet array of the device is configured torotate using one or more of geared, external helical, inner helical,slotted, and pin drive rotating or oscillating mechanisms, but is not solimited. Each of the rotation mechanisms used in various embodiments isdescribed in detail herein.

FIG. 44 shows a geared scalpet and an array including geared scalpets,under an embodiment. FIG. 45 is a bottom perspective view of a resectiondevice including the scalpet assembly with geared scalpet array, underan embodiment. The device comprises a housing (depicted as transparentfor clarity of details) configured to include the geared scalpet arrayfor the application of rotational torque for scalpet rotation. FIG. 46is a bottom perspective view of the scalpet assembly with geared scalpetarray (housing not shown), under an embodiment. FIG. 47 is a detailedview of the geared scalpet array, under an embodiment.

The geared scalpet array includes a number of scalpets as appropriate toa resection procedure in which the array is used, and a gear is coupledor connected to each scalpet. For example, the gear is fitted over oraround a scalpet, but the embodiment is not so limited. The gearedscalpets are configured as a unit or array so that each scalpet rotatesin unison with adjacent scalpets. For example, once fit, the gearedscalpets are installed together in alignment plates so that each scalpetengages and rotates in unison with its adjacent four scalpets and isthereby retained in precise alignment. The geared scalpet array isdriven by at least one rotating external shaft carrying a gear at thedistal end, but is not so limited. The rotational shaft(s) is configuredto provide or transmit the axial force, which compresses the scalpets ofthe array into the skin during incision. Alternatively, axial force maybe applied to the plates retaining the scalpets.

In an alternative embodiment, a frictional drive is used to drive orrotate the scalpets of the arrays. FIG. 48 shows an array includingscalpets in a frictional drive configuration, under an embodiment. Thefrictional drive configuration includes an elastomeric ring around eachscalpet, similar to gear placement in the geared embodiment, andfrictional forces between the rings of adjacent scalpets in compressionresults in rotation of the scalpets similar to the geared array.

The resection devices comprise helical scalpet arrays, including but notlimited to external and internal helical scalpet arrays. FIG. 49 shows ahelical scalpet (external) and an array including helical scalpets(external), under an embodiment. FIG. 50 shows side perspective views ofa scalpet assembly including a helical scalpet array (left), and theresection device including the scalpet assembly with helical scalpetarray (right) (housing shown), under an embodiment. FIG. 51 is a sideview of a resection device including the scalpet assembly with helicalscalpet array assembly (housing depicted as transparent for clarity ofdetails), under an embodiment. FIG. 52 is a bottom perspective view of aresection device including the scalpet assembly with helical scalpetarray assembly (housing depicted as transparent for clarity of details),under an embodiment. FIG. 53 is a top perspective view of a resectiondevice including the scalpet assembly with helical scalpet arrayassembly (housing depicted as transparent for clarity of details), underan embodiment.

The helical scalpet configuration comprises a sleeve configured to fitover an end region of the scalpet, and an external region of the sleeveincludes one or more helical threads. Once each scalpet is fitted with asleeve, the sleeved scalpets are configured as a unit or array so thateach scalpet rotates in unison with the adjacent scalpets.Alternatively, the helical thread is formed on or as a component of eachscalpet.

The helical scalpet array is configured to be driven by a push platethat oscillates up and down along a region of the central axis of thescalpet array. FIG. 54 is a push plate of the helical scalpet array,under an embodiment. The push plate includes a number of alignment holescorresponding to a number of scalpets in the array. Each alignment holeincludes a notch configured to mate with the helical (external) threadon the scalpet sleeve. When the push plate is driven it causes rotationof each scalpet in the array. FIG. 55 shows the helical scalpet arraywith the push plate, under an embodiment.

The resection devices further comprise internal helical scalpet arrays.The device comprises a housing configured to include the helical scalpetarray assembly for the application of rotational torque for scalpetrotation. FIG. 56 shows an inner helical scalpet and an array includinginner helical scalpets, under an embodiment. The inner helical scalpetincludes a twisted square rod (e.g., solid, hollow, etc.) or insert thatis fitted into an open end of the scalpet. Alternatively, the scalpet isconfigured to include a helical region. The twisted insert is held inplace by bonding (e.g., crimping, bonding, brazing, welding, gluing,etc.) a portion of the scalpet around the insert. Alternative, theinsert is held in place with an adhesive bond. Inner helical scalpetsare then configured as a unit or array so that each scalpet isconfigured to rotate in unison with the adjacent scalpets. The helicalscalpet array is configured to be driven by a drive plate that moves oroscillates up and down along the helical region of each scalpet of thescalpet array. The drive plate includes a number of square alignmentholes corresponding to a number of scalpets in the array. When the driveplate is driven up and down it causes rotation of each scalpet in thearray. FIG. 57 shows the helical scalpet array with the drive plate,under an embodiment.

FIG. 58 shows a slotted scalpet and an array including slotted scalpets,under an embodiment. The slotted scalpet configuration comprises asleeve configured to fit over an end region of the scalpet, and thesleeve includes one or more spiral slots. Alternatively, each scalpetincludes the spiral slot(s) without use of the sleeve. The sleevedscalpets are configured as a unit or array so that the top region of theslots of each scalpet are aligned adjacent one another. An externaldrive rod is aligned and fitted horizontally along the top of the slots.When the drive rod is driven downward, the result is a rotation of thescalpet array. FIG. 59 shows a portion of a slotted scalpet array (e.g.,four (4) scalpets) with the drive rod, under an embodiment. FIG. 60shows an example slotted scalpet array (e.g., 25 scalpets) with thedrive rod, under an embodiment.

FIG. 61 shows an oscillating pin drive assembly with a scalpet, under anembodiment. The assembly includes a lower plate and a middle platecoupled or connected to the scalpet(s) and configured to retain thescalpet(s). A top plate, or drive plate, is positioned in an area abovethe scalpet and the middle plate, and includes a drive slot or slot. Apin is coupled or connected to a top portion of the scalpet, and a topregion of the pin extends beyond a top of the scalpet. The slot isconfigured to receive and loosely retain the pin. The slot is positionedrelative to the pin such that rotation or oscillation of the top platecauses the scalpet to rotate or oscillate via tracking of the pin in theslot.

One or more components of the scalpet device include an adjustmentconfigured to control the amount (e.g., depth) of scalpet exposureduring deployment of the scalpet array at the target site. For example,the adjustment of an embodiment is configured to collectively control alength of deployment of the scalpets of a scalpet array. The adjustmentof an alternative embodiment is configured to collectively control alength of deployment of a portion or set of scalpets of a scalpet array.In another example embodiment, the adjustment is configured toseparately control a length of deployment of each individual scalpet ofa set of scalpets or scalpet array. The scalpet depth control includesnumerous mechanisms configured for adjustable control of scalpet depth.

The depth control of an embodiment includes an adjustable collar orsleeve on each scalpet. The collar, which is configured for movement(e.g., slideable, etc.) along a length of the scalpet, is configured toprevent penetration of the scalpet into target tissue beyond a depthcontrolled by a position of the collar. The position of the collar isadjusted by a user of the scalpet device prior to use in a procedure,where the adjustment includes one or more of a manual adjustment,automatic adjustment, electronic adjustment, pneumatic adjustment, andadjustment under software control, for example.

The depth control of an alternative embodiment includes an adjustableplate configured for movement along a length of scalpets of the scalpetarray. The plate is configured to prevent penetration of the scalpets ofthe scalpet array into target tissue beyond a depth controlled by aposition of the plate. In this manner, the scalpet array is deployedinto the target tissue to a depth equivalent to a length of the scalpetsprotruding beyond the plate. The position of the plate is adjusted by auser of the scalpet device prior to use in a procedure, where theadjustment includes one or more of a manual adjustment, automaticadjustment, electronic adjustment, pneumatic adjustment, and adjustmentunder software control, for example.

As an example of depth control adjustment using a plate, the variablelength scalpet exposure is controlled through adjustments of the scalpetguide plates of the scalpet assembly, but is not so limited. FIG. 62shows variable scalpet exposure control with the scalpet guide plates,under an embodiment. Alternative embodiments control scalpet exposurefrom within the scalpet array handpiece, and/or under one or more ofsoftware, hardware, and mechanical control.

Embodiments include a mechanical scalpet array in which axial force androtational force are applied manually by the compressive force from thedevice operator. FIG. 63 shows a scalpet assembly including a scalpetarray (e.g., helical) configured to be manually driven by an operator,under an embodiment.

Embodiments include and/or are coupled or connected to a source ofrotation configured to provide optimal rotation (e.g., RPM) androtational torque to incise skin in combination with axial force.Optimal rotation of the scalpets is configured according to the bestbalance between rotational velocity and increased cutting efficiencyversus increased frictional losses. Optimal rotation for each scalpetarray configuration is based on one or more of array size (number ofscalpets), scalpet cutting surface geometry, material selection ofscalpets and alignment plates, gear materials and the use oflubrication, and mechanical properties of the skin, to name a few.

Regarding forces to be considered in configuration of the scalpets andscalpet arrays described herein, FIG. 64 shows forces exerted on ascalpet via application to the skin. The parameters considered indetermining applicable forces under an embodiment include the following:

-   -   Average Scalpet Radius: r    -   Scalpet Rotation Rate: ω    -   Scalpet Axial Force: F_(n) (scalpet applied normal to skin)    -   Skin Friction Coefficient: μ    -   Friction Force: F_(f)    -   Scalpet Torque: τ    -   Motor Power: P_(hp)

Upon initial application, the torque used to rotate the scalpet is afunction of the axial force (applied normally to the surface of theskin) and the coefficient of friction between the scalpet and the skin.This friction force initially acts on the cutting surface of thescalpet. At initial application of scalpet to skin:F _(f)=μ·F _(n)τ=F _(f)·rP _(hp)=τ·ω/63025

The initial force for the scalpet to penetrate the skin, is a functionof the scalpet sharpness, the axial force, the tensile strength of theskin, the coefficient of friction between the skin and the scalpet.Following penetration of the scalpet into the skin, the friction forceincreases as there are additional friction forces acting on the sidewalls of the scalpet.

Resection devices of embodiments include kinetic impaction incisiondevices and methods for non-rotational piercing of the skin. Approachesfor direct compression of the scalpet into the skin include, but are notlimited to, axial force compression, single axial force compression pluskinetic impact force, and moving of the scalpet at a high velocity toimpact and pierce the skin. FIG. 65 depicts steady axial forcecompression using a scalpet, under an embodiment. Steady axial forcecompression places the scalpet in direct contact with the skin. Once inplace, a continuous and steady axial force is applied to the scalpetuntil it pierces the skin and proceeds through the dermis to thesubcutaneous fat layer.

FIG. 66 depicts steady single axial force compression plus kineticimpact force using a scalpet, under an embodiment. Steady single axialforce compression plus kinetic impact force places the scalpet in directcontact with the skin. An axial force is applied to maintain contact.The distal end of the scalpet is then struck by another object,imparting additional kinetic energy along the central axis. These forcescause the scalpet to pierce the skin and proceed through the dermis tothe subcutaneous fat layer.

FIG. 67 depicts moving of the scalpet at a velocity to impact and piercethe skin, under an embodiment. The scalpet is positioned a shortdistance away from a target area of the skin. A kinetic force is appliedto the scalpet to achieve a desired velocity for piercing the skin. Thekinetic force causes the scalpet to pierce the skin and proceed throughthe dermis to the subcutaneous fat layer.

Scalpets of an embodiment include numerous cutting surface or bladegeometries as appropriate to an incision method of a procedure involvingthe scalpet. The scalpet blade geometries include, for example, straightedge (e.g., cylindrical), beveled, multiple-needle tip (e.g., sawtooth,etc.), and sinusoidal, but are not so limited. As but one example, FIG.68 depicts a multi-needle tip, under an embodiment.

The scalpets include one or more types of square scalpets, for example.The square scalpets include but are not limited to, square scalpetswithout multiple sharpened points, and square scalpets with multiplesharpened points or teeth. FIG. 69 shows a square scalpet without teeth(left), and a square scalpet with multiple teeth (right), under anembodiment.

The fractional resection devices of an embodiment involve the use of asquare scalpet assembled onto a scalpet array that has multiplesharpened points to facilitate skin incising through directnon-rotational kinetic impacting. The square geometry of the harvestedskin plug provides side-to-side and point-to-point approximation of theassembled skin plugs onto the adherent membrane. Closer approximation ofthe skin plugs provides a more uniform appearance of the skin graft atthe recipient site. In addition, each harvested component skin plug willhave additional surface area (e.g., 20-25%).

Further, the scalpets include one or more types of elliptical or roundscalpets. The round scalpets include but are not limited to, roundscalpets with oblique tips, round scalpets without multiple sharpenedpoints or teeth, and round scalpets with multiple sharpened points orteeth. FIG. 70 shows multiple side, front (or back), and sideperspective views of a round scalpet with an oblique tip, under anembodiment. FIG. 71 shows a round scalpet with a serrated edge, under anembodiment.

The resection device of an embodiment is configured to include extrusionpins corresponding to the scalpets. FIG. 72 shows a side view of theresection device including the scalpet assembly with scalpet array andextrusion pins (housing depicted as transparent for clarity of details),under an embodiment. FIG. 73 shows a top perspective cutaway view of theresection device including the scalpet assembly with scalpet array andextrusion pins (housing depicted as transparent for clarity of details),under an embodiment. FIG. 74 shows side and top perspective views of thescalpet assembly including the scalpet array and extrusion pins, underan embodiment.

The extrusion pins of an embodiment are configured to clear retainedskin plugs, for example. The extrusion pins of an alternative embodimentare configured to inject into fractional defects at the recipient site.The extrusion pins of another alternative embodiment are configured toinject skin plugs into pixel canisters of a docking station forfractional skin grafting.

Embodiments herein include the use of a vibration component or system tofacilitate skin incising with rotation torque/axial force and to usevibration to facilitate skin incising with direct impaction withoutrotation. FIG. 75 is a side view of a resection device including thescalpet assembly with scalpet array assembly coupled to a vibrationsource, under an embodiment.

Embodiments herein include an electro-mechanical scalpet arraygenerator. FIG. 76 shows a scalpet array driven by an electromechanicalsource or scalpet array generator, under an embodiment. The function ofthe generator is powered but is not electronically controlled, butembodiments are not so limited. The platform of an embodiment includescontrol software.

Embodiments include and/or are coupled or connected to a supplementaryenergy or force configured to reduce the axial force used to incise skin(or another tissue surface such as mucosa) by a scalpet in a scalpetarray. Supplemental energies and forces include one or more ofrotational torque, rotational kinetic energy of rotation (RPM),vibration, ultrasound, and electromagnetic energy (e.g., RF, etc.), butare not so limited.

Embodiments herein include a scalpet array generator comprising and/orcoupled to an electromagnetic radiation source. The electromagneticradiation source includes, for example, one or more of a Radio Frequency(RF) source, a laser source, and an ultrasound source. Theelectromagnetic radiation is provided to assist cutting with thescalpets.

Embodiments include a scalpet mechanism configured as a “sewing machine”scalpet or scalpet array in which the scalpets are repeatedly retractedand deployed under one or more of manual, electromechanical, andelectronic control. This embodiment includes a moving scalpet or scalpetarray to resect a site row-by-row. The resection can, for example takethe form of a stamping approach where the scalpet or scalpet arraymoves, or the array could be rolled over the surface to be treated andthe scalpet array resection at given distances traveled to achieve thedesired resection density.

The fractional resection devices described herein are configured forfractional resection and grafting in which the harvesting offractionally incised skin plugs is performed with a vacuum that depositsthe plugs within the lumen of each scalpet shaft. The skin plugs arethen inserted into a separate docking station described herein by aproximal pin array that extrudes the skin plug from within the shaft ofthe scalpet.

FIG. 77 is a diagram of the resection device including a vacuum system,under an embodiment. The vacuum system comprises vacuum tubing and avacuum port on/in the device housing, configured to generate a vacuumwithin the housing by drawing air out of the housing. The vacuum of anembodiment is configured to provide vacuum stenting/fixturing of theskin for scalpet incising, thereby providing improved depth control andcutting efficiency.

The vacuum of an alternative embodiment is configured for vacuumevacuation or harvesting of skin plugs and/or hair plugs through one ormore of a scalpet lumen and an array manifold housing. FIG. 78 shows avacuum manifold applied to a target skin surface to evacuate/harvestexcised skin/hair plugs, under an embodiment. The vacuum manifold, whichis configured for direct application onto a skin surface, is coupled orconnected to a vacuum source. FIG. 79 shows a vacuum manifold with anintegrated wire mesh applied to a target skin surface toevacuate/harvest excised skin/hair plugs, under an embodiment.

Additionally, an external vacuum manifold is used with asuction-assisted lipectomy machine to percutaneously evacuatesuperficial sub-dermal fat through fractionally resection skin defectsin a fractionally created field for the treatment of cellulite. FIG. 80shows a vacuum manifold with an integrated wire mesh configured tovacuum subdermal fat, under an embodiment.

The external vacuum manifold can also be configured to include and bedeployed with an incorporated docking station (described herein) toharvest skin plugs for grafting. The docking station can be one or moreof static, expandable, and/or collapsible.

The fractional resection devices described herein comprise a separatedocking station configured as a platform to assemble the fractionallyharvested skin plugs into a more uniform sheet of skin for skingrafting. The docking station includes a perforated grid matrixcomprising the same pattern and density of perforations as the scalpetson the scalpet array. A holding canister positioned subjacent to eachperforation is configured to retain and maintain alignment of theharvested skin plug. In an embodiment, the epidermal surface is upwardat the level of the perforation. In an alternative embodiment, thedocking station is partially collapsible to bring docked skin plugs intocloser approximation prior to capture onto an adherent membrane. Thecaptured fractional skin graft on the adherent membrane is then defattedwith either an incorporated or non-incorporated transection blade. Inanother alternative embodiment, the adherent membrane itself has anelastic recoil property that brings or positions the captured skin plugsinto closed alignment. Regardless of embodiment, the contractedfractional skin graft/adherent membrane composite is then directlyapplied to the recipient site defect.

Embodiments include a collapsible docking station or tray configured toaccept and maintain orientation of harvested skin and/or hair plugs oncethey have been removed or ejected from the scalpets via the extrusionpins. FIG. 81 depicts a collapsible docking station and an inserted skinpixel, under an embodiment. The docking station is formed fromelastomeric material but is not so limited. The docking station isconfigured for stretching from a first shape to a second shape thataligns the pixel receptacles with the scalpet array on the handpiece.FIG. 82 is a top view of a docking station (e.g., elastomeric) instretched (left) and un-stretched (right) configuration, under anembodiment, under an embodiment.

The pixels are ejected from the scalpet array into the docking stationuntil it is full, and the docking station is then relaxed to itspre-stretched shape, which has the effect of bringing the pixels incloser proximity to each other. A flexible semi-permeable membrane withadhesive on one side is then stretched and placed over the dockingstation (adhesive side down). Once the pixels are adhered to themembrane, it is lifted away from the docking station. The membrane thenreturns to its normal un-stretched state, which also has the effect ofpulling the pixels closer to each other. The membrane is then placedover the recipient defect.

Resection devices described herein include delivery of therapeuticagents through resectioned defects generated with the resection devicesdescribed herein. As such, the resection sites are configured for use astopically applied infusion sites for delivery or application oftherapeutic agents for the reduction of fat cells (lipolysis) during orafter a resectioning procedure.

Embodiments herein are configured for hair transplantation that includesvacuum harvesting of hair plugs into the scalpet at the donor site, anddirect mass injection (without a separate collection reservoir) ofharvested hair plugs into the fractionally resected defects of therecipient site. Under this embodiment, the donor scalpet array deployedat the occipital scalp comprises scalpets having a relatively largerdiameter than the constituent scalpets of the scalpet array deployed togenerate defects at the recipient site. Following harvesting of hairplugs at the donor site, the defects generated at the recipient site areplugged using the harvested hair plugs transferred in the scalpet array.

Due to the elastic retraction of the incised dermis, the elasticallyretracted diameter of the hair plug harvested at the occipital scalpwill be similar to the elastically retracted diameter of thefractionally resected defect of the recipient site at thefrontal-parietal-occipital scalp. In an embodiment, hair plugs harvestedwithin the donor scalpet array are extruded directly with proximal pinsin the lumen of the scalpet into a same pattern of fractionally defectscreated by the recipient site scalpet array. The scalpets (containingthe donor hair plugs) of the scalpet array deployed at the donor siteare aligned (e.g., visually) with the same pattern of fractionallyresected field of defects at the recipient scalp site. Upon alignment, aproximal pin within the shaft of each scalpet is advanced down the shaftof the scalpet to extrude the hair plug into the fractionally resecteddefect of the recipient site, thereby effecting a simultaneoustransplantation of multiple hair plugs to the recipient site. This masstransplantation of hair plugs into a fractionally resected recipientsite (e.g., of a balding scalp) is more likely to maintain the hairshaft alignment with other mass transplanted hair plugs of thatrecipient scalp site. Directed closure of the donor site field isperformed in the most clinically effective vector, but is not solimited.

The fractional resection devices described herein are configured fortattoo removal. Many patients later in life desire removal of pigmentedtattoos for a variety of reasons. Generally, removal of a tattooinvolves the removal of the impregnated pigment within the dermis.Conventional tattoo removal approaches have been described from thermalablation of the pigment to direct surgical excision. Thermal ablation bylasers frequently results in depigmentation or area surface scarring.Surgical excision of a tattoo requires the requisite linear scarring ofa surgical procedure. For many patients, the tradeoff between tattooremoval and the sequela of the procedure can be marginal.

The use of fractional resection to remove a tattoo allows for fractionalremoval of a significant proportion of the dermal pigment with minimalvisible scarring. The fractional resection extends beyond the border ofthe tattoo to blend the resection into the non-resected and non-tattooedskin. Most apparently, de-delineation of the pattern of the tattoo willoccur even if all residual pigment is not or cannot be removed. In anembodiment, initial fractional resections are performed with a scalpetarray, and any subsequent fractional resections are performed bysingular scalpet resections for residual dermal pigment. As with otherapplications described herein, directed closure is performed in the mostclinically effective vector.

The fractional resection devices described herein are configured fortreatment of cellulite. This aesthetic deformity has resisted effectivetreatment for several decades as the pathologic mechanism of action ismultifactorial. Cellulite is a combination of age or weight loss skinlaxity with growth and accentuation of the superficial fat loculations.The unsightly cobblestone appearance of the skin is commonly seen in thebuttocks and lateral thighs. Effective treatment should address eachcontributing factor of the deformity.

The fractional resection devices described herein are configured forfractional resection of the skin in order to tighten the affected skinand to simultaneously reduce the prominent fat loculations that arecontributing to the cobblestone surface morphology. Through the samefractionally resected defects created for skin tightening, topicallyapplied vacuum is used to suction the superficial fat loculationspercutaneously. In an embodiment, a clear manifold suction cannula isapplied directly to the fractionally resected skin surface. Theappropriate vacuum pressure used with the suction-assisted lipectomy(SAL) unit is determined by visually gauging that the appropriate amountof sub-dermal fat being suction resected. The appropriate time period ofmanifold application is also a monitored factor in the procedure. Whencombined with fractional skin tightening, only a relatively small amountof fat is suction resected to produce a smoother surface morphology. Aswith other applications described herein, the fractionally resectedfield will be closed with directed closure.

The fractional resection devices described herein are configured forrevision of abdominal striae and scarring. Visually apparent scarring isa deformity that requires clear delineation of the scar from theadjacent normal skin. Delineation of the scar is produced by changes intexture, in pigment and in contour. To make a scar less visiblyapparent, these three components of scarring must be addressed for ascar revision to significantly reduce the visual impact. Severe scarscalled contractures across a joint may also limit the range of motion.For the most part, scar revisions are performed surgically where thescar is elliptically excised and carefully closed by careful coaptationof excised margins of the non-scarred skin. However, any surgicalrevision reintroduces and replaces the pre-existing scar with anincumbent surgical scar that may be also be delineated or only partiallyde-delineated by a Z or W plasty.

Scarring is bifurcated diagnostically into hypertrophic and hypotrophictypes. The hypertrophic scar typically has a raised contour, irregulartexture and is more deeply pigmented. In contrast, the hypotrophic scarhas a depressed contour below the level of the adjacent normal unscarredskin. In addition, the color is paler (depigmented) and the texture issmoother than the normal adjacent skin. Histologically, hypertrophicscars posses an abundance of disorganized dermal scar collagen withhyperactive melanocytes. Hypotrophic scars have a paucity of dermalcollagen with little or no melanocytic activity.

The fractional resection devices described herein are configured forfractional scar revision of a scar that does not reintroduce additionalsurgical scarring but instead significantly de-delineates the visualimpact of the deformity. Instead of a linear surgically induced scar,the fractional resection of the scar results in a net reduction of thepigmentary, textural and contour components. A fractional revision isperformed along the linear dimension of the scar and also extends beyondthe boundary of the scar into the normal skin. The fractional revisionof a scar involves the direct fractional excision of scar tissue withmicro-interlacing of the normal non-scarred skin with the residual scar.Essentially, a micro W-plasty is performed along the entire extent ofthe scar. As with other applications, the fractionally resected field isclosed with directed closure. An example of the use of fractionalrevision includes revising a hypotrophic post-partum abdominal stria.The micro-interlacing of the depressed scar epithelium and dermis of thestria with the adjacent normal skin significantly reduces the depressed,linear and hypo-pigmented appearance of this deformity.

The fractional resection devices described herein are configured forvaginal repair for postpartum laxity and prolapse. The vaginal deliveryof a full term fetus involves in part the massive stretching of thevaginal introitus and vaginal canal. During delivery, elongation of thelongitudinal aspect of the vaginal canal occurs along withcross-sectional dilatation of the labia, vaginal introitus and vaginalvault. For many patients, the birth trauma results in a permanentstretching of the vaginal canal along the longitudinal andcross-sectional aspects. Vaginal repair for prolapse is typicallyperformed as an anterior-posterior resection of vaginal mucosa withinsertion of prosthetic mesh. For patients with severe prolapse, thisprocedure is required as addition support of the anterior and posteriorvaginal wall is needed. However, many patients with post-partum vaginallaxity may be candidates for a less invasive procedure.

The fractional resection devices described herein are configured forfractional resection of the vaginal mucosa circumferentially to narrowthe dilated vaginal canal at the labia and the introitus. The patternfor fractional resection can also be performed in a longitudinaldimension when the vaginal canal is elongated. Directed closure of thefractional field can be assisted with a vacuum tampon that will act asstent to shaped the fractionally resected vaginal canal into apre-partum configuration.

The fractional resection devices described herein are configured fortreatment of snoring and sleep apnea. There are few health implicationsof snoring but the disruptive auditory effect upon the relationship ofsleeping partners can be severe. For the most part, snoring is due tothe dysphonic vibration of intraoral and pharyngeal soft tissuestructures within the oral, pharyngeal and nasal cavities duringinspiration and expiration. More specifically, the vibration of the softpalate, nasal turbinates, lateral pharyngeal walls and base of thetongue are the key anatomic structures causing snoring. Many surgicalprocedures and medical devices have had limited success in amelioratingthe condition. Surgical reductions of the soft palate are frequentlycomplicated with a prolonged and painful recovery due to bacterialcontamination of the incision site.

The fractional resection devices described herein are configured forfractional resection of the oropharyngeal mucosa in order to reduce theage related mucosal redundancy (and laxity) of intraoral and pharyngealsoft tissue structures and not be complicated with prolonged bacterialcontamination of the fractional resection sites. The reduction in sizeand laxity of these structures reduces vibration caused by the passageof air. A perforated (to spray a topical local anesthetic onto thefractional resection field) intraoral dental retainer (that is securedto the teeth and wraps around the posterior aspect of the soft palate)is used to provide directed closure in the anterior-posterior dimensionof the soft palate. A more severe condition called sleep apnea does haveserious health implications due to the hypoxia caused by upper airwayobstruction during sleep. Although CPAP has become a standard for thetreatment of sleep apnea, selective fractional resection of the base ofthe tongue and the lateral pharyngeal walls can significantly reducesleep related upper airway obstruction.

The fractional resection devices described herein are configured forfractional skin culturing/expansion, also referred to herein as“Culturespansion”. The ability to grow skin organotypically would be amajor accomplishment for patients with large skin defects such as burnsand trauma and major congenital skin malformations such port-wine stainsand large ‘bathing trunk’ nevi. Conventional capability is limited toproviding prolonged viability of harvested skin, although some reportshave indicated that wound healing has occurred with organotypic skincultured specimens. It has been reported that enhanced cultured outcomeswill occur with better substrates, cultured media and more effectivefiltration of metabolic byproducts. The use of gene expressionproteinomics for growth hormone and wound healing stimulation is alsopromising. To date however, there is no report that skin has been grownorganotypically.

The fractional harvesting of autologous donor skin for skin graftingunder an embodiment provides an opportunity in the organotypic cultureof skin that did not previously exist. The deposition of a fractionallyharvested skin graft onto a collapsible docking station, as provided bythe embodiments described herein, enables skin plugs to be brought intocontact apposition with each other. The induction of a primary woundhealing process can convert a fractional skin graft into a solid sheetby known or soon to be developed organotypic culture methodology.Further, the use of mechanical skin expansion can also greatly increasethe surface area of the organotypically preserved/grown skin. Invitrosubstrate device iterations include without limitation, an expandabledocking station comprising fractionally harvested skin plugs and aseparate substrate (e.g., curved, flat, etc.) expander that iscontrollable to provide a gradual and continual expansion of the fullthickness organotypically cultured skin. Additionally, the use oforganotypic skin expansion may provide a continual and synergisticwound-healing stimulus for organotypic growth. A gradual and continualexpansion is less likely to delaminate (the basement membrane) theepidermis from the dermis. Additionally, organotypic skin expansionhelps avoid the surgical risk and pain associated in-vivo skinexpansion.

The fractional resection devices described herein enable methods for theorganotypic expansion of skin. The methods comprise an autologousfractional harvest of skin from a donor site of a patient. The use of asquare scalpet array, for example, provides upon transfer side-to-sideand tip-to-tip coaptation of fractionally harvested skin plugs. Themethod comprises transfer of the fractional skin plugs to a collapsibledocking station that maintains orientation and provides apposition ofskin plugs. The docked skin plugs are captured onto a porous adherentmembrane that maintains orientation and apposition. The semi-elasticrecoil property of the adherent membrane provides additional contact andapposition of skin plugs. The method includes transfer of the adherentmembrane/fractional graft composite to a culture bay comprising asubstrate and a culture media that retains viability and promotesorganotypic wound healing and growth. Following healing of skin plugmargins, the entire substrate is placed into a culture bath that has amechanical expander substrate. Organotypic expansion is then initiatedin a gradual and continuous fashion. The expanded full thickness skin isthen autologously grafted to the patient's recipient site defect.

Organotypic skin expansion can be performed on non-fractional skingrafts or more generally, on any other tissue structure as organotypicexpansion. The use of mechanical stimulation to evoke a wound healingresponse for organotypic culture can also be an effective adjunct.

The embodiments described herein are used with and/or as components ofone or more of the devices and methods described in detail herein and inthe Related Applications incorporated herein by reference. Additionally,the embodiments described herein can be used in devices and methodsrelating to fractional resection of skin and fat.

Embodiments include a novel minimally invasive surgical discipline withfar-reaching advantages to conventional plastic surgery procedures.Fractional resection of skin is applied as new stand-alone procedures inanatomical areas that are off limits to conventional plastic surgery dueto the poor tradeoff between the visibility of the incisional scar andamount of enhancement obtained. Fractional resection of skin is alsoapplied as an adjunct to established plastic surgery procedures such asliposuction, and is employed to significantly reduce the length ofincisions required for a particular application. The shortening ofincisions has application in both the aesthetic and reconstructiverealms of plastic surgery. Without limitation, both the procedural andapparatus development of fractional resection are described in detailherein.

Embodiments described herein are configured to remove multiple smallsections of skin without scarring in lieu of the conventional linearresections of skin. The removal of multiple small sections of skinincludes removal of lax excess skin without apparent scarring. As anexample, FIG. 83 depicts removal of lax excess skin without apparentscarring, under an embodiment. The removal of multiple small sections ofskin also includes tightening of skin without apparent scaring, forexample, FIG. 84 depicts tightening of skin without apparent scaring,under an embodiment. The removal of multiple small sections of skinfurther includes fractional skin tightening in which the clinicalendpoint results in three-dimensional contouring of the skin envelop.FIG. 85 depicts three-dimensional contouring of the skin envelop, underan embodiment.

The clinical effectiveness of any surgical manipulation requires athrough understanding of the underlying processes that lead reliably toa clinical endpoint. For fractional skin tightening and contouring, anumber of mechanisms of action are described herein. The principlemechanism of action identified is the conversion of two-dimensionalfractional skin tightening into three-dimensional aesthetic contouring(e.g., see FIG. 3). Contributory to that principle clinical endpoint aresecondary mechanisms of action that serve in concert with each other.The contributory mechanisms of action are described herein according totheir capability to achieve the clinical endpoint, but are not solimited.

The density of fractional resection within an outlined fractional fieldis a primary determinate of two-dimensional skin tightening contributingto three-dimensional contouring. Generally, the density is thepercentage of fractionally resected skin within the fractional field butis not so limited. FIG. 86 depicts variable fractional resectiondensities in a treatment area, under an embodiment. The density offractional resection (“fractional density”) can be varied to providemore selected skin tightening and contouring while providing smoothertransitions into non-fractionally resected areas. Therefore, forexample, transitions into non-fractionally resected areas include areduction in the fractional density but are not so limited.

Another mechanism of action associated with fractional skin resection isthe fractional resection of fat. FIG. 87 depicts fractional resection offat, under an embodiment. Immediately subjacent to the skin are thesub-dermal and subcutaneous fat layers where a variable amount of fat(based on depth and/or amount) can be fractionally resected inanatomical continuity with the resected skin plug. A variable amount offat fractionally resected, and hence an amount of skin tightening andcontouring, is controlled in an embodiment by controlling one or more ofa depth of the resection at the target site and an amount of fatresected. Thus, the density of fractional resection (“fractionaldensity”) can be varied by controlling one or more of fractionaldensity, resection depth, and amount of fact resected in order toprovide more selected skin tightening and contouring while providingsmoother transitions into non-fractionally resected areas. Therefore,for example, transitions into non-fractionally resected areas include areduction in a combination of fractional density, resection depth, andamount of fact resected, but are not so limited.

An additional modality for fractional fat resection is the percutaneousvacuum resection (PVR) of fat directly through the skin fractionaldefects. Numerous clinical applications of fractional fat resection areanticipated in the embodiments herein. The most significant aestheticapplication of fractional fat resection is the reduction of cellulite.The combined in-continuity application of fractional skin and fatresection directly addresses the underlying pathology of this aestheticdeformity. The skin laxity and prominent loculations of fat producingvisible surface cobblestoning of skin morphology are each resolved inconcert with the application of this minimally invasive resectioncapability. FIG. 88 depicts cobblestoning of the skin surface.

Furthermore, another general application includes the ability to alterthree-dimensional contour abnormalities with a combined in-continuityapproach of fractional skin tightening and inward contouring fromfractional fat resection. The pre-operative topographical contourmapping of the fractional field assists in providing a more predictableclinical outcome. Essentially, a topographical mapping oftwo-dimensional fractional skin resection is combined with a variablemarking for fat resection. FIG. 89 depicts topographic mapping for adeeper level of fractional fat resection, under an embodiment. Mappingalso includes the feathering or transition zones into non-resected areaswhere the fractional density is reduced. Depending upon thepre-operative topographical marking of the patient, a variable amount offat is fractionally resected in continuity with fractional skinresection.

Areas to be corrected comprising convex contours undergo deeperfractional fat resections. Concave (or depressed) areas to be correctedare corrected using fractional skin resection. The net result within themapped fractional field is overall smoothing of three-dimensionalcontours with two-dimensional tightening of the skin.

The use of combined fractional resection is most apparent with thereduction in the length required for conventional plastic surgeryincisions and with the elimination of iatrogenic incisional skinredundancies (“Dog Ears”). Standard resection of skin lesions does notrequire the additional scarring of elliptical incisions but issignificantly reduced in the linear dimension required for closure of anexcised lesion (see FIG. 94).

An additional mechanism of action associated with fractional skinresection is the size of the overall outlined pattern of the fractionalresection field. The overall amount of fractionally resected skin alsodepends on the size of the fractionally resected field. The larger thefield, the more skin tightening occurs with a specified density offractional resection. FIG. 90 depicts multiple treatment outlines, underan embodiment.

The mechanism of action of a patterned outline includes the selectivecurvilinear patterning of each particular anatomical area for eachparticular patient. A topographical analysis with a digitally capturedimage of the patient involving a rendered (and re-rendered to anenhanced contour) digital wire mesh program assists in formatting thesize and curvilinear outline for a selected anatomical region andpatient. The pattern of standard aesthetic plastic surgery excisions fora particular anatomic region also assists in the formatting of thefractional resection pattern. FIG. 91 depicts a curvilinear treatmentpattern, under an embodiment. FIG. 92 depicts a digital image of apatient with rendered digital wire mesh program, under an embodiment.

Directed closure of a fractionally resected field of an embodimentprovides the capability of selectively tightening skin to achieveenhanced aesthetic contouring. For most applications, the closure occursat right angles to Langer's lines but may also be done at a differentdirection that achieves maximal aesthetic contour such as closures thatare based on resting skin tension lines. FIG. 93 depicts directedclosure of a fractionally resected field, under an embodiment. Thedirected closure may also follow known vectors of closure used inconventional plastic surgery procedures (e.g., facelift for thefacial/submental component of the facelift is upwards (corresponding toa horizontal directed closure of a fractional field) and the neckcomponent below the cervical mandibular angle is more obliquelyposterior (corresponding to a more vertical directed closure of thefractional field)). Multiple vectors of directed closure may also beused in more complicated topographical regions such as the face andneck.

Embodiments include directed fractional resection of skin, whichenhances the effectiveness of the procedure. This process is performedby pre-stretching the skin at right angles to the preferred direction ofmaximal skin resection. FIG. 94 depicts directed fractional resection ofskin, under an embodiment.

Embodiments include aesthetic contouring resulting from the mechanicalpull (or vector) created from an adjacent fractional field adjacent tothe targeted contour. This effect for a fractional field is based onplastic surgical procedures that are directed a distance from thetargeted contour. Further, variable topographical transitioning ofresection densities within the field and along the pattern outline arerealized, which provide selective contouring and smoother transitioninginto non-resected areas. Additionally, variable topographicaltransitioning of scalpet size resections within a patterned outline (andwith different scalpet sizes within an array) provides selectivetwo-dimensional skin tightening and three-dimensional contouring.

Embodiments described herein evoke a selective wound healing sequencewith promotion of primary healing during the immediate post-operativeperiod and delayed secondary contraction of skin during the collagenproliferative phase. Promotion of accurate coaptation of the skinmargins is inherent to the multiple (fractional) resections of smallsegments of skin i.e., skin margins are more closely aligned prior toclosure than larger linear resections of skin that are common withstandard plastic surgery incisions. Subsequent evoking of woundcontraction is also inherent to a fractionally resected field whereelongation of the pattern of fractional resection provides a directedwound healing response along the longitudinal dimension of thefractionally resected pattern.

Clinical methods of fractional skin resection involve methods ofdirectional closure. Depending upon the anatomical area, the directedclosure of excisional skin defects within a fractional resection fieldis achieved by following Langer's lines, the resting skin lines, and/orin a direction that achieves the maximal of aesthetic contouring. Thedirection in which closure is most easily achieved can also be used as aguide for the most effective vector of directed closure. For manyapplications, the use of Langer's lines is used as a guide to providemaximal aesthetic tightening. Following the original work of Dr. Langer,the fractionally resected defects will elongate in the direction of aLanger line. The directed closure is performed at right angles toLanger's lines in an anatomical region where the skin margins of eachfractional resection defect are in closest approximation.

In continuity fractional procedures that are deployed adjacent or incontinuity with plastic surgery incisions, the most significantcapability provided by the embodiments herein includes the ability toshorten incisions. The need for elliptical excisions of skin tumors isreduced in both the application of this technique and in the length ofthe incision. Thus, the need to excise the lateral extension of a tumorresection is obviated by the fractional resection at that same lateralaspect. FIG. 95 depicts shortening of incisions through continuityfractional procedures, under an embodiment.

As the fractional field under an embodiment heals without visiblescarring, the net result is significant reduction in the length of theexcisional scar. Another application within this category is theshortening of conventional plastic surgery incisions used for breastreduction, Mastopexy and abdominoplasty. The lateral extent of theseincisions can be shortened without the creation of “dog ear” skinredundancies that would otherwise occur with the same length incision.FIG. 96 is an example depiction of “dog ear” skin redundancies in breastreduction and abdominoplasty. For example, extensions of the incisionbeyond the lateral inframmary fold for breast reduction or beyond theIliac crest for abdominoplasty would no longer be required. Fractionalrevisions of post-operative “dog ear” skin redundancies could also beperformed without extension of the existing incision.

Embodiments include combined procedures that provide aestheticenhancement at both the fractional resection harvest site and arecipient site. The most apparent application of this method is the useof fractional harvesting of the cervical beard for hair transplantationin the frontal and parietal scalp. A dual benefit is created by theprocedure in which aesthetic contouring is created along the anteriorneck and with restoration of the hair bearing scalp.

Embodiments include separate fractional procedures in anatomical areasthat are not currently addressed by plastic surgery due to the poortradeoff between the visibility of the surgical incision and the amountof aesthetic enhancement. Several examples exist in this category suchas the supra-patellar knee, the upper arm, the elbow, bra skinredundancy of the back, and the medial and lateral thighs and theinfragluteal folds.

Embodiments include adjunct fractional procedures that are deployed withconventional plastic surgery incisions in a non-contiguous fashion. Thiscategory includes suction-assisted lipectomy in which subcutaneous fatis removed by suction in areas of lipodystrophy such as the lateral hipsand thighs. However, many patients have pre-existing skin laxity that isaggravated by suction lipectomy. The tightening of the skin envelopeover these areas by fractional resection has several benefits to thesepatients. Many patients with skin laxity and lipodystrophy becomecandidates for liposuction who otherwise not qualify for the procedure.For patients without preexisting skin laxity but with more significantlipodystrophy, a larger contour reduction can be performed withoutiatrogenic skin laxity. The procedure can be deployed as a singlecombined procedure for smaller fractional resections or as a stagedprocedure.

Directed closure of the fractional field is performed without suturingand is achieved with the application of an adhesive stent membrane asdescribed in detail herein. The fractional field is closed with anadhesive membrane using a number of methods. An example method includesanchoring the membrane outside the perimeter of the fractional field.Tension is then applied to the opposite end of the adhesive membrane.The body of the adhesive membrane is then applied to the fractionalfield row by row to the remaining skin within the field. The directionof application follows the selected vector of directed closure. Thisdirection of application at times is at right angles to Langer's linesbut is not so limited, and any direction of application can be chosenthat provides maximal aesthetic contouring.

Another method includes use of the elastic property of the adherentstent dressing to selectively close a fractional field. With thismethod, the ends of the elastic stent dressing are stretched orpreloaded, and the stent dressing is then applied to the fractionalfield. Upon release of the ends of the membrane, the elastic recoil ofthe stent dressing closes the fractional defects in a direction that isat right angles to the elastic recoil.

Embodiments described in detail herein include a skin Pixel ArrayDermatome, also referred to herein as a “sPAD”. The sPAD is a gangedmultiple-scalpet array comprising a multiplicity of individual circularscalpels. The circular configuration enables rotational torque to beapplied to the skin to facilitate incising. A coupling or linkage of thescalpets to an electromechanical power source is provided by series ofgears between each scalpet and a drive shaft, as described herein. Inaddition, a vacuum is created within a housing and configured forstenting stabilization during incising. The same vacuum capability canalso be applied as a pneumatic assist to apply additional axial (Z-axis)force during the incising duty cycle. Another vacuum application is theevacuation of incised skin plugs in the fractional field.

The sPAD includes numerous configurations as described in detail herein.FIG. 97 is a sPAD including a skived single scalpet with depth control,under an embodiment. FIG. 98 is a sPAD including a standard singlescalpet, under an embodiment. FIG. 99 is a sPAD including a pencil-stylegear reducing handpiece, under an embodiment. FIG. 100 is a sPADincluding a 3×3 centerless array, under an embodiment.

An instrument comprising a surgical drill is provided for use with thesPAD. FIG. 101 is a sPAD including a cordless surgical drill for largearrays, under an embodiment. FIG. 102 is a sPAD comprising a drillmounted 5×5 centerless array, under an embodiment.

Embodiments include a Vacuum Assisted Pneumatic Resection (VAPR) ArraysPAD, also referred to herein as a “VAPR sPAD”. FIG. 103 is a sPADincluding a vacuum assisted pneumatic resection sPAD, under anembodiment. The VAPR sPAD uses vacuum pressure configured to drive thescalpets from the sPAD into the treatment site. The VAPR sPAD is coupledor connected to a drill via a Drill Array Coupling (DAC). FIG. 104 is aVAPR sPAD coupled to a drill via a DAC, under an embodiment. The DACfixes the housing of the VAPR sPAD to the drill, while the hexagonaltubing allows the VAPR sPAD drive shaft to slide up and down during thetreatment. An externally supplied vacuum (not shown) is coupled orconnected to the VAPR sPAD via the vacuum port.

FIG. 105 depicts the VAPR sPAD in a ready state (left), and an extendedtreatment state (right), under an embodiment. With the vacuum and drilloperating, a single treatment cycle comprises placing the VAPR sPADagainst the treatment site, creating a seal between the housing and thetreatment site. Once this seal is established, the vacuum pulls thepiston with the rotating gears into the treatment site. After thedesired depth of cutting has been achieved the SPAD is pulled away fromthe treatment site. This breaks the seal, and the spring inside the sPADforces it back into its ready state. The cycle can now be repeated at anew treatment site.

Embodiments include a Spring Assisted Vacuum Resection (SAVR) sPAD,which operates in a similar manner to the VAPR sPAD. FIG. 106 depictsthe SAVR sPAD in a ready state (left), and a retracted state (right),under an embodiment. The SAVR sPAD is coupled or connected to the drillvia the DAC. The vacuum port is attached to a separate vacuum supply.The drive shaft slides back and forth within the tube attached to thedrill.

In the SAVR sPAD, the spring and vacuum locations have generally beenreversed from the VAPR sPAD. The spring and vacuum port are both locatedon the proximal side of the piston but are not so limited. The vacuumassists in drawing the skin pixels out through the scalpets and henceaway from the treatment site. The spring provides the axial force forthe rotating scalpets to drive into the treatment site and resect theskin. The scalpets are extended outside the housing in array readystate.

The treatment cycle starts with the placement of the scalpets over thedesired treatment location. The vacuum is turned on and the drill isapplied downward, forcing the piston and scalpets back up into thehousing (retracted state). The drill is turned, causing the scalpets torotate. The spring force coupled with the scalpet rotation results inthe resection. The vacuum draws the pixels generated by the resection upinto and subsequently out of the housing. Once the desired cutting depthhas been achieved, the SAVR sPAD is lifted off the treatment site andthe cycle can be repeated.

Embodiments are described herein comprising instrumentation andprocedures for aesthetic surgical skin tightening including, but notlimited to, instruments or devices, and procedures that enable therepeated harvesting of skin grafts from the same donor site whileeliminating donor site deformity. Embodiments herein include devicesconfigured for fractional resection and corresponding methods orprocedures, including single-scalpet and multi-scalpet array platformsusing a vacuum manifold. Additional disclosure of corresponding devicesconfigured for fractional resection and corresponding methods orprocedures is found in the Related Applications, each of which is hereinincorporated by reference in its entirety. Regarding the use of vacuumin a fractionally resected field, the vacuum manifold is configured toapply vacuum intraluminally within the scalpet (or within amulti-scalpet array). Alternatively, the vacuum manifold is configuredto apply vacuum extraluminally as either a component of the scalpetassembly or as a separate manifold device that is directly applied tothe skin of the fractional field.

Applications of the vacuum capacity of the scalpet assembly include thesuction evacuation of fractionally incised skin plugs (e.g., FIGS. 108,112, and 113). Furthermore, applications of the vacuum capacity of thescalpet assembly include the vacuum stabilization of the skin surfaceduring fractional resection (e.g., FIGS. 109 and 114). Additionalapplications of the vacuum capacity of the scalpet assembly includefractional vacuum-assisted lipectomy of the subcutaneous and subdermalfat layer (e.g., FIG. 114).

FIG. 107A is a cross-sectional side view of a vacuum aspiratorconfigured to be coupled or attached in series with a vacuum manifoldand scalpet array, under an embodiment. FIG. 107B is an isometriccross-sectional view of a vacuum aspirator configured to be coupled orattached in series with a vacuum manifold and scalpet array, under anembodiment. FIG. 107C is a solid side view of a vacuum aspiratorconfigured to be coupled or attached in series with a vacuum manifoldand scalpet array, under an embodiment.

FIG. 108A is a cross-sectional side view of a scalpet array used with avacuum aspirator, under an embodiment. FIG. 108B is an isometriccross-sectional view of a scalpet array used with a vacuum aspirator,under an embodiment. FIG. 108C is a solid side view of a scalpet arrayused with a vacuum aspirator, under an embodiment.

FIG. 109A is a cross-sectional side view of a vacuum manifold configuredto be coupled or connected to a vacuum aspirator, under an embodiment.FIG. 109B is an isometric cross-sectional view of a vacuum manifoldconfigured to be coupled or attached to a vacuum aspirator, under anembodiment. FIG. 109C is a solid side view of a vacuum manifoldconfigured to be coupled or attached to a vacuum aspirator, under anembodiment. The vacuum aspirator is coupled or connected in series withthe vacuum manifold and is configured as one or more of a specificallyadapted aspirator for fractional resection, and a device such as aconventional surgical aspirator or an aspirator used specifically forsuction assisted lipectomy (SAL). In an embodiment, the intraluminalvacuum scalpet or scalpet array has a rotary component to enhance both askin incisional and fat suction curettage capability, but is not solimited.

Vacuum delivery of the device of an embodiment is controlled an aperturecomponent configured for manipulation by a device operator. FIG. 110 isa solid side view of the device with the vacuum component configured formanual control via an aperture, under an embodiment. Alternatively, thevacuum component is controlled electronically. For example, the cyclingon/off of the vacuum source is at least in part computer controlled(e.g., computer controlled duty cycle, etc.). The electronic controllercan also be used to cycle a change in the rotary (RPM) component of thescalpet assembly. Scalpet length may also be one or more of manually andcomputer controlled.

The vacuum manifold of an embodiment includes a “slip on” overlayencasement in a region of the distal end of the hand piece (e.g., FIG.109). The vacuum manifold is also extended distally onto the scalpet toserve as a depth guide. Various depth guide-dependent vacuum manifoldsaddress different clinical applications and variable dermal depths atdifferent anatomical sites. In an embodiment, a plastic manifold iscreated as a single procedure disposable that has a separate vacuum portincorporated into the manifold. In an alternative embodiment, the vacuumcapability is an “in-line” or “in-series” configuration of the handpiecethrough which the vacuum is applied internally and can extend down thelength of the scalpet proximally or is diverted through a separate sideaperture of the scalpet. FIG. 111A is an isometric view of a handpiececonfigured to include or incorporate vacuum, under an embodiment. FIG.111B is an isometric cutaway view of the handpiece configured to includeor incorporate vacuum, under an embodiment.

FIG. 112 is a cross-sectional side view of a single-scalpet deviceapplied to a target tissue site, under an embodiment. FIG. 113 is anisometric cross-sectional view of a single-scalpet device applied to atarget tissue site, under an embodiment. FIG. 114A is a cross-sectionalside view of a multi-scalpet device applied to a target tissue site,under an embodiment. FIG. 114B is an isometric cross-sectional view of amulti-scalpet device applied to a target tissue site, under anembodiment. The scalpet devices of various embodiments include one ormore scalpets. The scalpet types of an embodiment include one or more ofa slotted scalpet and a slotted blunt micro-tip cannula. FIG. 115 is anexample slotted scalpet, under an embodiment. FIG. 116 is an exampleslotted blunt micro-tip cannula, under an embodiment.

The ability to fractionally suction subdermal/subcutaneous fat underembodiments herein has several applications depending upon the targetanatomical region. These applications include without limitation, theflattening of a convex three-dimensional contour and the inwardcontouring of an anatomical region to restore an aesthetic feature suchas the submentum and the cervical-mandibular angle, for example. Forthese applications, a side-slotted aperture scalpet and a blunt tipside-slotted aperture fractional cannula are described herein (e.g.,FIGS. 114 and 115). The blunt tip cannula is configured for use inanatomical regions where key vascular or nerve structures areimmediately subjacent to the fractional lipectomy field. Regardless ofthe type of scalpet/cannula, the combining of the rotary function of thesystem with a vacuum capability provides a means to more effectivelysuction curette the subdermal/subcutaneous fat layer.

Embodiments include, without limitation, fractional marking systemsconfigured as guides to assure an adequate fractional resection density.The guides include, for example, a stencil and/or AdherentSemitransparent Perforated Plastic Membrane Guide (ASPPMP) configuredfor use as a guide for fractional resection. The stencil marking systemincludes a stencil (e.g., ink, etc.) comprising a grid pattern of eithercircles or dots that is temporarily applied preoperatively to a targetsite. FIG. 117 is an example ink stencil marking system, under anembodiment. The circles or dots include at least one of a positive and anegative stencil of the grid pattern, and the ink material isbiocompatible and configured to not smear or degrade during prepping ofthe patient or during the conduct of the procedure.

The ASPPMP marking system includes an adherent semitransparentperforated plastic membrane. FIG. 118 shows the adherent semitransparentperforated plastic membrane, under an embodiment. The perforated plasticmembrane is also configured to serve as a depth guide that assures thatthe prescribed depth of fractional resection is not exceeded. FIG. 119Ashows a side view of the ASPPMP in use as a depth guide with thesingle-scalpet device, under an embodiment. FIG. 119B shows a topisometric view of the ASPPMP in use as a depth guide with thesingle-scalpet device, under an embodiment.

Clinical applications of the single-scalpet and multi-scalpet arrayplatform include aesthetic contouring, which is most effectivelyproduced by a combination of skin tightening and inward contouring of anembodiment, but is not so limited. The ability to fractionally resectskin and fat during a procedure has produced a significant capabilityover previous electromagnetic devices and aesthetic plastic surgeryprocedures because the fractional resection includes the direct removalof skin (in an area of skin laxity) without visible scarring. Theenhanced capability of an embodiment to fractionally resect skin iscombined with fractional subdermal/subcutaneous lipectomy to restoremore youthful aesthetic contours.

FIG. 120 shows fractional resection of skin and fractionalsubdermal/subcutaneous lipectomy, under an embodiment. An example offractional resection of skin and fractional subdermal/subcutaneouslipectomy, without limitation, is the treatment of the submentum (underthe chin). FIG. 121 shows a side view of the submentum as a target areafor fractional resection of skin and fractional subdermal/subcutaneouslipectomy, under an embodiment. FIG. 122 shows an inferior view (lookingupward) of the fractional resection field submentum as a target area forfractional resection of skin and fractional subdermal/subcutaneouslipectomy, under an embodiment. The presence of skin laxity andprominence of the submental fat pad are the main components of thisaesthetic deformity. Each patient will have a variable amount of eachsoft tissue component requiring a selective correction tailored orconfigured for each particular patient. More specifically, the convexcontour of the submentum is caused predominately by lipodystrophy of thesubmental fat pad and the loss of the cervical-mandibular angle ispredominately due to skin laxity.

Patients typically present with a variable amount of submentum skinlaxity and lipodystrophy, so embodiments use planning and marking of apatient for a specific procedure. The combined capability of theassembly of an embodiment correlates well with the need to modify thespecific soft tissue components of the aesthetic deformity. For patientswith more severe skin laxity, a larger horizontally aligned treatmentarea in the submentum and lateral neck is marked for fractional skinresection. FIG. 123 shows a horizontally aligned treatment area in thesubmentum and lateral neck for severe skin laxity, under an embodiment.

For patients will more severe lipodystrophy, a broader fractionallipectomy (through fractional resection skin defects) is marked withinthe treatment area. The depth of the fractional lipectomy may also beselectively altered to address the topographic features of this convexcontour deformity. FIG. 124 shows broader fractional lipectomy in thesubmentum for severe lipodystrophy, under an embodiment.

Clinical applications of the single-scalpet and multi-scalpet arrayplatform include directed closure specifications. To promote primaryhealing (healing per primum) that reduces scarring, an accurate closureof the incision is a key principle employed in plastic surgeryprocedures. However, the direction of the closure is also important foraesthetic contouring. The appropriate vector of skin tightening takesinto account the anatomical structure to be aesthetically enhanced. Formore complicated aesthetic contours such as the face and neck, multiplevectors of sign tightening are employed during a procedure.

FIG. 125 shows example face vector and neck vector directed closures,under an embodiment. In addition to the skin tightening vectors, variouslines of closure also limit tension upon closure. Lines of closureinclude those described by Karl Langer, and FIG. 126 shows Langer'slines of closure. Closure of skin incisions as indicated by Langer'slines promotes primary healing because it reduces the tension of theclosure. When there is conformity between the vector of skin tighteningand Langer's lines, the resultant aesthetic contouring and primaryhealing will work in concert with each other to provide the optimalclinical outcome.

Embodiments herein include stepwise procedure algorithms configured toprovide a more uniform reduction to practice that produces predictableclinical outcomes. Many of the procedural steps (and the sequences ofsteps) herein are unique developments for fractional resectionprocedures. Without limitation, a procedural algorithm is included forthe fractional resection of the submentum.

According to the treatment procedures of an embodiment, initially, apatient is marked preoperatively in a sitting position. For patientswith relatively more skin laxity, the area outlined for fractionalresection is broader and extends onto the lateral neck. For patientswith relatively little or no skin laxity, the outlined fractionalresection area is limited to the area in which lipodystrophy of thesubmentum fat pad is producing a convex contour deformity. For patientswith both skin laxity and lipodystrophy, both areas are individuallyoutlined as components of a single combined treatment outline. FIG. 127shows marked target areas for fractional resection of neck and submentallipectomy, under an embodiment.

To avoid a reduction in the fractional field density, a local anestheticfield block is administered to the demarcated area of thesubmentum/neck. A dot/circle stencil is then applied to assure adequacyof the fractional resectional density, as described in detail herein.FIG. 128 shows an example marking stencil, under an embodiment. Theseprocedure steps can be reversed where stenciling is performed prior toinjection of the local anesthetic. The distension of the stenciled skincan be compensated with a larger outlined treatment area. A fractionalskin resection is then performed within the boundary of the entiredemarcated treatment area.

Fractional lipectomy is limited to the topographically outlined area oflipodystrophy (e.g., FIG. 127) and is performed either during fractionalskin resection or as a subsequent procedural step. Transitioning orfreehand feathering beyond the demarcated outline is performed tode-delineate the boundary of the fractional resection. A directedclosure of the fractional defects is performed with an absorbentadherent elastic bandage that is stretched (preloaded) in the preferredvector of closure/skin tightening.

The bandage (e.g., Flexzan, etc.) can be preloaded by first applying oneend of the bandage at a lateral mooring point beyond the fractionalfield. Once secure, the load is then applied at the opposite end of thebandage. The load is maintained during application. An alternativeloading technique is to first apply opposing loads at each lateralextend of the elastic bandage i.e., the bandage is first stretched alongthe longitudinal axis of the material prior to application. With theload being maintained, the elastic bandage is then fully applied to thefractional field. Release of the load results in an elastic recoil thatcloses the defects of the fractional field along the designated vector.In the submentum where skin laxity of the anterior neck is present, abi-directional closure with two vectors is pursued, but embodiments arenot so limited.

FIG. 129 shows example directed closure vectors of the submentum andanterior neck, under an embodiment. The vector for the anterior neck(below the submentum) is more transverse and is used to accentuate thecervical-mandibular angle. For the submentum, the vector of closure (asindicated by Langer's lines) is vertical. A sterile dressing is thenapplied to conclude the procedure. A compression garment is also appliedto provide compression and vectored support during the post-operativephase.

Embodiments include fractional scar revision. The reduction of thevisible impact of a pre-existing scar deformity has been a major focusof plastic surgery since the inception of this surgical specialty.Depending upon the type of scar deformity, different surgical techniqueshave been employed. A commonly employed technique is elliptical excisionof the scar with a layered closure. Other techniques such as Z-plastyand W-plasty attempt to reduce the linearity of the scar. FIG. 130depicts Z-plasty and W-plasty scar revision. However, these conventionaltechniques lengthen the scar deformity. Fractional scar revision isconfigured to reduce the visible impact of the scar without lengtheningof the scar.

For linear scar deformities, embodiments include a fractionalde-delineation technique in which an interdigitating fractionalresection is performed along each margin of the scar. To maximizede-delineation, directed closure of the fractional field is performed atright angles to the linear scar. FIG. 131 shows an example of thefractional de-delineation technique of scar resection, under anembodiment.

Additional de-delineation is produced under an embodiment with freehandfractional resection beyond the margins of the scar. Embodiments includea fractional technique for broad hypotrophic scars that occur fromshaved biopsy excisions of skin lesions. To reduce the width of the scardeformity, a fractional scar excision is performed within the margin ofthe scar. Directed closure is performed as described in detail herein.FIG. 132 shows an example of the fractional scar resection for broadhypotrophic scars, under an embodiment. Another alternative embodimentcombines both fractional scar revision techniques where the combinedrevision is performed as a single procedure or as a planned sequence ofprocedures, but is not so limited.

Additional embodiments include application of fractional resection toshorten incisions required to excise lesions. This novel capability canalso be applied to shorten longer plastic surgery incisions that areused to resect redundant skin. The elliptical extension of an incision(to avoid a “dog-ear” skin redundancy) is no longer required if thelateral aspect of each incision is fractionally resected using devicesand methods described herein.

The fractional procedure can be performed concurrently or as a plannedsubsequent revision of the primary excisional procedure. Fractionalresection of embodiments can also be used for pre-existing dog-earredundancies post excision. An example is the shortening of theinframmary incision required for breast reduction and breastrepositioning. FIG. 133 shows an example comprising shortening of theinframmary incision as applied to breast reduction and/or breastrepositioning, under an embodiment. The incision becomes less visible asit no longer extends beyond the inframmary fold.

Embodiments described herein include fractional skin grafting. Thisincludes the closure of full thickness skin defects, which has also beena primary focus of plastic surgeons. Large defects that cannot be closedby direct closure require a more complicated approach. The twoconventional approaches developed by plastic surgery are flap closureand skin grafting. FIG. 134 shows an example flap closure. Local ordistant flap closures require an intrinsic or pedicle blood supply thatis harvested with the flap at the donor site. Flap closure of skindefects is also complicated by the formation of additional scarring atthe donor site.

Skin grafting (either split thickness or full thickness) is the otherapproach used to close large full thickness skin defects. Using the skingrafting approach, skin graft donor sites are required and areassociated with significant scarring and morbidity.

After the several decades in which these two plastic surgical approacheshave been employed, a novel third approach is now described in theembodiments herein. Fractional skin grafting can avoid the side effectsassociated with sheet skin grafting because fractional skin grafting hasthe unique capability to avoid the donor site deformity associated withsheet skin grafting. Fractional skin grafting also provides theadditional capability to harvest subsequent skin grafts from the samedonor site. FIG. 135 shows an example comprising fractional skin graftharvesting to be applied to a donor site, under an embodiment.

Fractional skin grafting is especially important with patients havinglarge surface area burns for which donor site availability is severelylimited. This unique capability of serial harvest at the same donor siteis also important in patients with skin defects of the lower extremitythat are caused by reduced circulation. Patients such as these withvenous stasis, ischemic and diabetic ulcers are especially at risk tosustain the loss of the extremity if skin coverage of the vascularcompromised ulcer is not promptly obtained. Many of these patients mustundergo a sequence of skin grafts before skin coverage is obtained. Themorbidity associated with this prolonged skin grafting process involvingmultiple donor sites can be especially vexing in patients who also haveother serious systemic conditions. With fractional skin graftingdescribed herein, the absence of a single visible donor site deformitycoupled with the capability of serial harvesting of skin grafts from thesame donor site provides a uniquely capable treatment option for thesepatients. In comparison to split thickness skin graft donor sites, thedirected closure of the fractional donor site provides more rapidhealing that dramatically reduces donor site morbidity and scarring.

As the fractional skin graft of an embodiment is full thickness, thedurability of the skin coverage is also enhanced over split thicknessskin grafts. For wound healing in these compromised recipient sites, theapplication of the fractional skin graft can be performed without theforming of the fractional skin segments (pixels) onto a more uniformsheet. In this clinical setting, “side neovascularization” occursbetween the individual fractional skin segments and the recipient bed.FIG. 136 shows an example comprising neovascularization of a fractionalskin graft at a recipient site, under an embodiment. The recipient sitefunctions as a biological docking station that organizes the fractionalskin segments into a side orientation with the recipient bed. For othernon-compromised and more visible skin defects, embodiments include theoption to first form the fractionally harvested skin segments into amore uniform graft at a mechanical docking station. FIG. 137 shows anexample docking station comprising a docking tray and adjustable slides,under an embodiment. In this clinical setting, “bottom upneovascularization” occurs from the recipient bed into deep aspect ofdermis (e.g., FIG. 136). With each clinical setting, a compressive stentdressing provides additional support and immobilization that promotesneovascularization or “take” of the skin graft.

Since the advent of bovine collagen injection filler, the use ofnon-biological injectables has taken a dominant role in the fillermarket. Embodiments described herein include a novel collagen injectablefiller composition, the production and use of which comprises the novelaesthetic surgical discipline of fractional skin resection described indetail herein and in the Related Applications. The novel filler ofembodiments herein is referred to as Live Autologous Dermal Matrix(LADMIX) Injectable Filler, or “LADMIX,” but is not so limited. TheLADMIX comprises a biological collagen injectable configured as a uniqueadjunct to the fractional resection of skin where the fractionallyresected dermal plugs (also referred to herein as “pixels,” “skinpixels,” or “skin plugs”) are used as a donor tissue to create a liveautologous dermal injectable filler. Although dermal matrix is not“living” by itself, the presence of live fibroblasts in the injectedfiller continuously produces collagen as a live biological dermalfiller. As the filler material is from the patient's own skin,resorption of the filler is minimized and the contour correction is morelong-term than conventional artificial fillers. Further, immunologicalor foreign body rejection is also minimized or avoided.

FIG. 138 shows a face having target tissue that includes, for example,furrows and folds. The LADMIX injection provides a significant benefitto these commonly occurring aesthetic deformities. Under the embodimentsherein, skin plugs of a fractional resection that might otherwise bediscarded are harvested insitu from the skin surface. FIG. 139 shows afractionally incised field (skin plugs insitu), under an embodiment. Thecombined procedure of fractional skin tightening and LADMIX fillerinjection is performed concurrently, but is not so limited.

The skin plugs are harvested insitu from the fractionally incised fieldwith application of an adherent substrate, for example, doubly adherentdermatome tape, and/or as described in detail herein and in the RelatedApplications. FIG. 140 is a detailed view of fractional skin resectiondefect harvesting, under an embodiment. The external orientation of theepidermis is maintained during the harvesting process, as described indetail herein. The skin plugs can either be harvested with the membraneapplied directly to a dermatome or the plugs can be separately harvestedonto the membrane and then applied to the dermatome. FIG. 141 shows anexample with skin plugs harvested using a membrane applied directly to adrum dermatome, under an embodiment, and as described in detail herein.FIG. 142 shows removal of the epidermal component by transecting theskin plugs generated by the dermatome with an outrigger blade of thedermatome, under an embodiment. FIG. 143 shows skin plugs separatelyharvested onto a membrane, and the membrane is then applied to adermatome (e.g., drum), under an embodiment.

The harvested dermal plugs are collected for morselization into theLADMIX preparation or composition. The device used for morselization isconfigured to mechanically mince the dermal plugs into a viscous liquidthat minimizes fibroblast cellular disruption. FIG. 144 shows anon-compressive moreselizer configured to mechanically mince the dermalplugs into a viscous liquid, under an embodiment.

The LADMIX preparation is loaded into a syringe with a large bore needlefor injection. Prior to injection, a local anesthetic (e.g., 1%Xylocaine with epinephrine) is injected into the furrow of thewrinkle/fold deformity. The injection of a local anesthetic providesboth anesthesia and lifting of the furrow that facilitates the injectionof the LADMIX filler. The injection of the LADMIX filler is performedwith a syringe and large bore needle with the needle tip down, forexample. The needle tip is inserted into the longitudinal axis of thefurrow but is not so limited. FIG. 145 shows injection of the LADMIXfiller at a target tissue site, under an embodiment. Advancing theneedle along the furrow of the deformity auto dissects the filler pocketwhile the LADMIX filler is being injected. The injected autologousfiller is then manually massaged into a smooth surface contour. Asteristrip is then applied over the injected furrow to stent and retainthe corrected surface contour.

An example embodiment of the scalpet device includes a multi-scalpetarray comprising a multi-functional chamber, and is configured for thesimultaneous resection and collection of multiple pixels. The collectionchamber, also referred to herein as the “chamber,” is configured topreserve the viability and the volume of the autologous injectablefiller and, further, is configured to serve one or more functionsincluding, for example, acting as a collection chamber or receptacle forresected pixels, a mincing chamber for mincing the collected dermalplugs, a mixing chamber for mixing the minced tissue with hyaluronicacid or saline solution, and/or a transfer vessel or loading station formoving the minced pixel solution to a hypodermic, to name a few.

The multi-functional chamber, when configured or used for the collectionchamber function, passively collects harvested dermal plugs by pushingthe plugs into the chamber. At the end of this phase of duty cycle, amultifunctional port is configured for short periods of vacuumextraction of dermal plugs within the lumen of the scalpets. The chamberis otherwise kept at ambient atmospheric pressure to pressure theviability of the dermal plugs. An “O-ring” is included in a distalregion of the central drive shaft (e.g., at the investing plate) toavoid retrograde gear particle contamination. A separate detachable(vacuum assisted) epidermal extraction chamber can be used first duringthe initial fractional resection pass, but embodiments are not solimited.

The multi-functional chamber, when configured or used for the mincingchamber function, receives a rotating mincing blade coupled or attachedto the central drive shaft. During the harvest phase of the duty cycle,the central scalpet drive shaft and mincing blade are retractedproximally to avoid continuous mincing of the harvested dermal plugs.During the mincing phase of the duty cycle, the central drive shaft andmincing blade are advanced distally for a prescribed time period.

The multi-functional chamber, when configured or used for the mixingchamber function, receives a carrier fluid via syringe through amultifunctional chamber port. Carrier fluids can include one or more ofsaline, hyaluronic acid, hydrogels and bioactive factors such as dermalgrowth factor, for example.

The multi-functional chamber, when configured or used for the syringeloading chamber function, is configured for drawing or extracting theminced composition into a syringe via the multifunctional port forsubsequent injection onto the target or recipient site.

More specifically, FIG. 146 shows an example of a scalpet deviceincluding a multi-functional chamber, under an embodiment. Themulti-scalpet array of the scalpet device of this example embodimentincludes a centerless 3×3 multi-scalpet array configured for theresection and collection of eight (8) pixels simultaneously, but is notso limited. The device includes a handpiece coupled to or including acentral drive shaft or pinion coupled to a drive system (e.g., gears,etc.) and driving rotation of eight scalpets (no scalpet in centerposition of 3×3 array). A vacuum is applied through a vacuum port of thedrive system housing (e.g., gearbox, etc.) to minimize and/or eliminatetransfer of gear debris to the pixel chamber, but the embodiment is notso limited. The collection chamber or chamber is configured to serve oneor more functions including, for example, acting as a collectionreceptacle for resected pixels, a mixing chamber for mincing and mixingthe pixels with hyaluronic acid or saline solution, and/or a transfervessel for moving the minced pixel solution to a hypodermic, to name afew. A size (e.g., diameter, etc.) of the collection chamber is selectedbased on, for example, the volume or number of pixels to be collected inthe collection chamber.

The housing includes or is coupled to an end cap at the distal end ofthe scalpet device, and the end cap of an embodiment is detachable butis not so limited. A length of the end cap may vary depending on thedepth of resection desired. Alternatively, the end cap is attached viaan internal spring configured to extend the end cap over the scalpetswhen not in use. Once the end cap has been installed, vacuum tubing isconnected to the vacuum port of the drive system housing. This assuresthe effective removal of any gear debris, and in combination with themesh buffer plate assures the resected pixels are free from any unwantedmaterials. The scalpet device and/or the vacuum are configured to pullthe resected pixels through the scalpets (e.g. lumen and proximal endregion) and into the collection chamber, but are not so limited. FIG.147 shows an example vacuum flow path through the scalpet device, underan embodiment.

FIG. 148 shows an example scalpet device following collection of pixelsin the collection chamber, under an embodiment. Following completion ofa portion of a harvesting procedure and/or collection in the chamber ofsufficient dermal plugs or pixels, the handpiece with the attachedscalpet array is inverted, allowing the pixels to collect at theproximal end of the collection chamber. The end cap is removed and thevacuum fitting and fastening screw are replaced with two plugs. FIG. 149shows an inverted handpiece with pixels in the collection chamber, underan embodiment. The collection chamber is configured to receive orcontain a saline and/or other desired solution or composition, which isadded to the pixels. An alternative end cap with a Luer or similarfitting plug is attached, and the handpiece with the chamber is revertedback to its original orientation. FIG. 150 shows the inverted handpiecewith the alternative end cap and fitting plug installed, under anembodiment.

The handpiece is then detached from the chamber, fitted with a mincingblade, and is then re-attached to the collection chamber. FIG. 151 showsthe handpiece with mincing blade attached and positioned in thecollection chamber with the pixel solution, under an embodiment. Thepixel solution is minced to the desired consistency using the mincingblade, thereby forming the LADMIX filler. The mincer is then removed,and a syringe is attached to the end cap. The LADMIX filler is drawninto the syringe from the collection chamber, and the LADMIX filler isready to be injected into a target tissue site using the needle attachedto the syringe. FIG. 152 shows the LADMIX filler drawn into the syringe,under an embodiment. FIG. 153 shows the syringe and attached needlereadied for injecting the LADMIX filler into the target tissue site,under an embodiment.

Harvesting tissue in an embodiment for use in preparing the LADMIXincludes removal of the epidermis, which avoids the occurrence ofepidermal inclusion cysts at the recipient injection site. The removalof the epidermis and the harvest of dermal plugs is accomplished using amethod including, but not limited to, one or more of delamination of theepidermis, dermabrasion of the epidermis, vacuum assisted two-passtechnique, and the two-pass technique with injection. Each of thesemethods is described in detail herein.

The delamination of the epidermis from the dermis comprises blisteringthe skin either within the entire fractional field or at individualfractional sites. FIG. 154 shows a skin blister formed within an entirefractional field, under an embodiment. FIG. 155 shows the fractionalfield following removal of the blistered tissue overlying the entirefractional field, under an embodiment. FIG. 156 shows formation ofmultiple skin blisters, under an embodiment. FIG. 157 shows multiplefractional fields following removal of the blistered tissue overlyingthe fractional fields, under an embodiment. The blistering of anembodiment is performed using vacuum-assisted mechanical vibratoryshearing with heat. The blistering of an alternative embodiment isperformed using vacuum-assisted mechanical vibratory shearing withoutheat. Yet another alternative embodiment for skin blister formationincludes superficial injection of a local anesthetic or normal saline atthe epidermal/dermal junction with the use of a short multiple needleinjection manifold. Additional alternatives include vacuum assist and/ormechanical shearing and/or heat, but embodiments are not so limited.

Subsequent to the skin blistering, dermal plug harvesting is appliedwith a single pass of either a single scalpet system or with a multiplescalpet array as described in detail herein. FIG. 158 shows harvestingof dermal plugs within a blistered region using a single scalpet systemor a multiple scalpet array, under an embodiment.

The removal of the epidermis and the harvest of dermal plugs of analternative embodiment involves dermabrasion of the epidermis from thedermis. The entire fractional donor field is dermabraded with a standarddermabrasion system, but embodiments are not so limited. Alternatively,removal of the epidermis is accomplished by dermabrading each individualfractional site with a small rotatory burr powered by the single scalpetconsole described herein.

Another alternative embodiment for removal of the epidermis and theharvest of dermal plugs involves use of a vacuum assisted two-passmethod or process. The first fractional resection pass is performedsuperficially to remove the epidermis and a small portion of thepapillary dermis (inclusion of the papillary dermis into the harvesteddermal plug is important as a higher density of fibroblasts are presentin that portion of the dermal layer). The second fractional harvestingpass is performed full thickness through the dermis. The elastic recoilof the skin defect margins of the first fractional pass providesadditional clearance of the fractional defect skin edges for the secondharvest pass. As with other methods described herein, the incised dermalplug is then vacuum evacuated and collected into an inline scaledvolumetric collection canister, for example.

An embodiment of the vacuum assisted two-pass method includes anadditional method to provide epidermal margin clearance. This additionalmargin clearance method is used during the second fractional harvestingpass in which the scalpet/array is first inserted into the fractionaldefects without rotation. When fully inserted into the fractional defectof the first pass, the rotation of the console is then initiated for thesecond harvest pass.

An additional alternative embodiment for removal of the epidermis andthe harvest of dermal plugs involves use of the vacuum assisted two-passmethod with a superficial injection of a local anesthetic or normalsaline. This method minimizes the unwanted resection of the papillarydermis during the first pass.

Regardless of the method used for removal of the epidermis and harvestof the dermal plugs, the harvested dermal plugs are collected in acollection canister as described herein. FIG. 159 shows a collectionvessel or canister including harvested dermal plugs, under anembodiment. Upon completion of harvesting, the dermal plugs areretrieved from the collection canister and inserted into a mincercontainer. FIG. 160 shows a mincer container or canister includingharvested dermal plugs, under an embodiment. The mincer container isconfigured for use in mincing or cutting the dermal plugs into smallpieces configured for injection, but is not so limited.

Mincing of an embodiment is performed with minimal trauma in order topreserve the viable fibroblasts. For this purpose, the mincer includesone or more of manual, rotary, oscillating, and reciprocatingultra-sharp blade(s) without compressive morselization. FIG. 161 shows amanual mincer including a blade device configured to be manipulatedup/down and/or rotated, under an embodiment. FIG. 162 shows an electricmincer including a blade or cutting device configured to be rotatedunder power, under an embodiment. The rotation is imparted to the bladedevice with one or more of an electric motor, pneumatic motor, and ahand- or machine-operated device, but is not so limited.

The mincer container of an embodiment is also configured for use as amixing chamber in which a carrier fluid/gel is added to the dermaltissue. The carrier fluid of embodiments includes one or more ofhyaluronic acid, hydrogel, and normal saline, to name a few. To reducesurface loses and trauma to the injectable, the mincing container of anembodiment is configured as a loading chamber including a plunger and aport that directly loads the living autologous composition into theinjection syringe. Prior to injection in the recipient site, the syringemay also be placed onto a centrifuge for separation of the liquefied fatfrom the dermal composition. A reduced friction syringe (e.g., glass,plastic, etc.) is used to further reduce trauma to the living autologouscomposition during injection.

The LADMIX harvest of an embodiment is configured to enable use ofexcised skin during plastic surgery procedures such as a facelift,abdominoplasty, mastopexy and/or breast reduction, to name a few. Thecombined procedure of an embodiment includes, but is not limited to,during the same plastic surgery procedure, placing (and adhering) theexcised skin on a Padget dermatome using an adherent membrane tape. Theskin is oriented down with epidermis in contact with the dermatome tape,but is not so limited. The epidermis is then removed by setting thedermatome on a superficial setting. The subcutaneous tissue can then beremoved manually by instrumental defatting or with a second pass withthe dermatome on a deep setting. The isolated dermal layer of theexcised skin is then minced as described herein.

Injection of the LADMIX is performed in an embodiment at the time orduring the same procedure as the fractional skin resection, but is notso limited. Combining these two procedures together as a singleprocedure provides a unique capability for aesthetic enhancement. Thecombined procedure also provides a unique capability for the treatmentof depressed scar deformities where the living dermal composition isharvested from a fractional scar revision field. The procedure can alsobe applied for certain physiological disease states that can beidentified, one example of which is the treatment of stress incontinencein women.

Procedures or methods using the LADMIX are configured for application tonumerous different clinical methods or applications, including but notlimited to one or more of aesthetic, reconstructive scar, andphysiological disease states. Generally, the procedures include takingor obtaining detailed pre-operative photographs of the patient orsubject. The patient is marked pre-operatively in either a standing orsitting position. The four-to-one rule is used, for example, todetermine the overall size of the fractional resection field, butembodiments are not so limited. A smaller topographically-marked portionwithin the field may also be used to serve as the donor site for theharvest of the dermal plugs.

Preoperative sedation and prophylactic antibiotics are provided (e.g.,intravenous, oral, etc.) as appropriate to a patient and/or procedure,and the patient is taken into the operating room where an anesthetic isadministered as appropriate for the procedure to be performed. Theoperative area is prepped and draped in a sterile fashion. A local fieldor tumescent anesthetic is then injected into the operative site. Adilute solution of Xylocaine with epinephrine (e.g., 0.5% Xylocaine with1 in 200,000 parts epinephrine for a field block, or 0.25% Xylocainewith 1 in 400,000 parts epinephrine for a tumescent anesthetic) is usedto provide anesthesia (and vasoconstriction to reduce bleeding).

A marking system template or stencil is then applied to the operativesite. The marking system template of an embodiment comprises aperforated and notched plate configured for use of corners of the plateto demarcate an adequate fractional density resection at the donor site.FIG. 163 is an example marking system template, under an embodiment. Theperipheral notches are configured for orientation during application ofthe template, and the perforations indicate the density for thefractional resection where the surgeon “fills in” the interveningfractional resections freehand. Further, the marking template isconfigured for use in marking the operative site with ink, for example,or with a direct fractional marking resection through largerperforations within the template.

The fractional resection of an embodiment comprises a staggeredtechnique of fractional resection in order to reduce the delineation ofthe rows and columns of the fractional resection field. Within the donorregion of the field, a two-pass technique is used for the dermalharvest, as described in detail herein. The fractional field is thenclosed with Flexzan, or other elastic absorbent material, using a vectorof directed closure that provides the maximum of aesthetic contouring. Asterile dressing is then applied to the combined fractional skin/fatresection/dermal donor site.

The harvested dermal plugs are then processed and injected into thepreviously marked recipient site during the same procedure to preservethe viability of the live autologous filler. After instillation of thelocal anesthetic, the recipient pocket for the injectable is created byfirst advancing the large bore needle of the syringe along the length ofthe previously marked depressed deformity. FIG. 164 shows creation ofthe recipient pocket for the injectable, under an embodiment. The largebore needle is then slowly retracted back while the autologous filler isinjected along the entire length of the created pocket. FIG. 165 therecipient pocket with the injected filler, under an embodiment.

More particularly, an example procedure protocol involving the LADMIXinjectable is described in detail. The donor and recipient sites aremarked while the patient is in preoperative holding. The donor site inthis example involves the non-hirsute right lower quadrant (RLQ) of theabdomen. The recipient sites will be the dorsum of the left hand andappendectomy scar in the RLQ.

With the patient in the operating room, a subdermal field block (e.g.,0.5% Xylocaine with 1 in 200,000 parts Epinephrine) is administered atthe donor site of the RLQ of the abdomen. Another infiltration injectedsuperficially at the dermal epidermal junction (without blistering) willalso be administered throughout the demarcated area. Both recipientsites at the dorsum of the left hand and the depressed appendectomy scarreceive a standard subdermal field block using the same localanesthetic. The donor and recipient sites are then prepped and draped ina sterile fashion.

The first pass of fractional resection at the donor site is performedwith a depth stop/vacuum manifold (e.g., 1 mm depth stop/vacuummanifold) using a scalpet (e.g., 2 mm inside diameter) without an inlinefilter in the vacuum line. This initial pass is performed to remove theepidermis with as little papillary dermis as possible.

The second dermal harvest pass at the donor site is performed with aninline filter in place with a depth stop/vacuum manifold (e.g., 4-6 mmdepth stop/vacuum manifold) using a scalpet (e.g., 1.5 mm insidediameter). The filter should be inserted as close to the manifold aspossible. The scalpet/manifold is cleared periodically with normalsaline in order to collect and hydrate all harvested dermal plugs intothe filter.

The harvested dermal plugs are removed from the filter and placed intothe mincer where a small volume of normal saline is added. Theautologous composition is created by the mincing of the dermal plugswith normal saline but is not so limited. The composition is loaded (byaspiration) into a filler injection syringe using a short blunt-tip17-gauge needle. A 22-gauge cannula is then used to inject thecomposition into the recipient sites.

A sample of the composition is first applied to a microscopic slide forviability staining to determine the viability of harvested fibroblasts.The first recipient site on the dorsum of the left hand is injected, forexample, using a technique developed by Dr. Stephen Yoelin. To createthe pocket, the cannula is first advanced without injection. Thecomposition is then injected as the cannula is retracted in a retrogradefashion within the pocket.

The second recipient site of the depressed appendectomy scar is injectedif an adequate amount of the injectable is available after injection ofthe first recipient site. Three months later the injected appendectomyscar will be excised for histologically evaluation to determine thelong-term invivo structure and viability of the injected composition.

Determined by Langer's lines, for example, a directed closure of the RLQdonor site is performed with the application of Flexzan using the singlemooring technique. Both recipient injection sites are manuallymanipulated to smooth contour. Steristrips (one-half inch) are thenlongitudinally applied to the recipient sites as a stent. A standarddressing of 4×4s and an ABD pad is applied over the Flexzan of the donorsite.

Clinical applications of the LADMIX filler described herein includeaesthetic applications, reconstructive applications, and physiologicapplications, but embodiments are not so limited. The aestheticapplications include but are not limited to furrows, wrinkles, folds,and general aesthetic contouring. Furrows include aesthetic deformitiescaused by the attachment to facial muscle and are accentuated duringanimation of the anatomical region. The Glabellar furrows are the mostfrequently referenced aesthetic furrow deformity. The LADMIX compositionis used to treat furrows by injecting the LADMIX subdermal, for example,between the skin and the muscle.

Wrinkles are for the most part caused by a linear atrophy of dermalcollagen matrix. A superficial intradermal injection of LADMIX iseffective for a long-term amelioration of the aesthetic deformities.

The prominence of folds, in particular the nasolabial fold, is due inpart to progressive skin laxity of this structure. Injection of LADMIXalong the margin of the nasolabial fold with the upper lip and alargroove provides a more youthful transition between these two structures.

Regarding general aesthetic contouring, for women, a prominentvermillion cutaneous junction and upper lip can be interpreted bysociety as aesthetically enhanced. LADMIX injections along thevermillion cutaneous junction of the upper lip provide a long termaccentuation of this anatomical structure. The potential also exists forlonger lasting lip augmentation.

The reconstructive applications of the LADMIX include but are notlimited to applications involving scars and soft tissue contourdeformities. Further, these applications require an understanding of theanatomical basis of the deformity. Depressed scar deformities, forexample, have a scar attachment to a deeper tissue layer. In most cases,a release of the subjacent scar attachment is required during the sameprocedure involving the subdermal injection of the LADMIX composition.

Many depressed soft tissue contour deformities are due to a traumaticlipolysis of the subcutaneous fat layer. Following the release of thedepressed deformity, the injection should be between the skin and thesubjacent subcutaneous tissue.

The physiologic applications of the LADMIX include but are not limitedto female incontinence, gastroesophageal reflux, and vocal cord voicemodulation, for example. When being applied to treat femaleincontinence, the injection of a viable, autologous collagen fillerprovides a longer lasting physiologically support than a non-viablexenographic injectable. FIG. 166 shows treatment of female incontinenceusing injection of LADMIX, under an embodiment.

Patients with gastroesophageal reflux disease are resistant topharmacological management that reduce gastric acidity. The injection ofvarious sclerotic agents has been attempted with mixed results. Theinjection of LADMIX to the distal esophageal sphincter reduces thereflux of gastric contents. Combining the pharmacological management ofgastric acidity with endoscopic LADMIX injection (as a physicalimpediment) would synergistically reduce the symptoms and incidencegastric-esophageal regurgitation.

The LADMIX described herein is used in clinical applications for vocalcord voice modulation. Poor or incomplete apposition of the vocal cordscan lead to a variety of voice dysphonias. Submucosal injection ofLADMIX into the vocal cords provides positive voice modulation inselected patients.

Embodiments include a method comprising identifying a donor site on asubject. The method includes removing a portion of the epidermis withinthe donor site. The method includes harvesting a plurality of dermalplugs within the donor site. The method includes forming an injectablefiller by mincing the dermal plugs. The method includes injecting theinjectable filler into a recipient site on the subject. The recipientsite is different from the donor site.

Embodiments include a method comprising: identifying a donor site on asubject;

removing a portion of the epidermis within the donor site; harvesting aplurality of dermal plugs within the donor site; forming an injectablefiller by mincing the dermal plugs; and injecting the injectable fillerinto a recipient site on the subject, wherein the recipient site isdifferent from the donor site.

The injectable filler comprises a live autologous dermal matrix (LADMIX)injectable filler.

The injectable filler comprises live fibroblasts.

The removing the portion of the epidermis comprises removing the portionof the epidermis in a region of the donor site.

The removing the portion of the epidermis comprises removing the portionof the epidermis in a plurality of regions of the donor site.

The removing the portion of the epidermis comprises delaminating theepidermis from the dermis in at least one region of the donor site.

The delaminating comprises blistering skin.

The delaminating comprises blistering skin at the donor site.

The delaminating comprises vibratory shearing.

The vibratory shearing comprises at least one of vacuum and heat.

The delaminating comprises superficial injection.

The superficial injection comprises at least one of saline andanesthetic.

The removing the portion of the epidermis comprises dermabrasion of theepidermis from the dermis in at least one region of the donor site.

The harvesting the plurality of dermal plugs comprises fractionallyresecting at least one dermal plug from at least one region of the donorsite.

The harvesting the plurality of dermal plugs comprises fractionallyresecting at least one dermal plug from each of a plurality of regionsof the donor site.

The harvesting the plurality of dermal plugs comprises at least onefractional resection application at the donor site.

The at least one fractional resection application includes a staggeredfractional resection application at the donor site.

The at least one fractional resection application at the donor sitecomprises a first fractional resection application and a secondfractional resection application.

The first fractional resection application comprises removal ofepidermis.

The second fractional resection application comprises fractionalresection through the dermis.

The second fractional resection comprises a partial-thickness fractionalresection through the dermis.

The second fractional resection comprises a full-thickness fractionalresection through the dermis.

A fractional defect skin edge of the second fractional resectionapplication comprises additional clearance relative to the fractionaldefect skin edge of the first fractional resection application.

The method includes inserting at least one scalpet into the at least onedonor region and, when fully inserted, rotating the at least onescalpet.

The fractionally resecting comprises positioning at a target site ahousing comprising a scalpet assembly, wherein the scalpet assemblyincludes a scalpet array and at least one guide plate, wherein thescalpet array includes a plurality of scalpets, wherein the at least oneguide plate maintains a configuration of the plurality of scalpets.

At least one scalpet of the scalpet array comprises a cylindricalscalpet including a cutting surface on a distal end of the scalpet.

The fractionally resecting comprises deploying the scalpet array fromthe housing into tissue at the target site and generating a plurality ofincised dermal plugs at the target site when deployed, wherein thedeploying includes coupling a force of a drive system of the scalpetassembly to the scalpet array

The fractionally resecting comprises applying rotational force to thescalpet array, wherein the rotational force is configured to rotate atleast a set of the plurality of scalpets.

The plurality of scalpets is configured to passively extrude the dermalplugs through a plurality of lumens of the plurality of scalpets.

The method includes delivering a vacuum to the target site via thehousing, wherein the vacuum comprises pressure relatively lower thanambient air pressure, and capturing the plurality of incised dermalplugs using the vacuum.

The fractionally resecting comprises retracting the scalpet array intothe housing from the target site.

The method includes capturing the plurality of incised dermal plugsusing an adherent substrate.

The method includes transecting the incised dermal plugs using a cuttingmember.

The fractionally resecting comprises applying a scalpet array to atarget skin site, wherein the scalpet array comprises a plurality ofscalpets positioned on an investing plate, wherein the investing plateis a perforated plate.

The fractionally resecting comprises circumferentially incising dermalplugs at the target skin site by applying a load via the scalpet arrayonto subjacent skin surface that includes the target skin site.

The applying the load comprises applying the load with a dermatome.

The dermatome includes a flat dermatome.

The dermatome includes a drum dermatome.

The fractionally resecting comprises capturing a plurality of inciseddermal plugs on an adherent substrate, wherein the incised dermal plugsare extruded through the scalpet array.

The method includes coupling the adherent substrate to the dermatome.

The fractionally resecting comprises transecting bases of incised dermalplugs extruded through the scalpet array.

The transecting comprises transecting with a cutting member.

The cutting member is coupled to the drum dermatome.

The method includes collecting the plurality of dermal plugs harvestedat the donor site.

The method includes collecting the plurality of dermal plugs in acollection chamber coupled to the scalpet array.

The collection chamber is configured for at least one of receiving thedermal plugs, collecting the dermal plugs, mincing the dermal plugs,mixing the dermal plugs with a carrier, and a loading chamber forloading a composition comprising the dermal plugs into at least one of aneedle and an injection cannula.

The collection chamber includes a pressurized chamber.

The collection chamber includes an unpressurized chamber.

The collection chamber is configured for the mincing, wherein themincing comprises mincing the dermal plugs in the collection chamber.

The harvesting comprises fractional resection by applying rotationalforce to the scalpet array, wherein the mincing comprises mincing thedermal plugs in the collection chamber with at least one bladeconfigured for rotation by the rotational force.

The forming of the injectable filler comprises mixing the minced dermalplugs with a carrier, wherein the collection chamber is configured as amixing chamber for the mixing.

The injecting comprises injecting using at least one of a needle and aninjection cannula, wherein the collection chamber is configured as aloading chamber for the at least one of the needle and the injectioncannula.

The collecting comprises evacuating the plurality of dermal plugs fromthe donor site.

The mincing comprises mincing the dermal plugs with at least one blade.

The mincing comprises at least one of manual mincing and poweredmincing.

The mincing comprises rotary mincing.

The mincing comprises reciprocating mincing.

The mincing comprises oscillating mincing.

The mincing excludes compressive mincing.

The mincing includes compressive morselization.

The forming of the injectable filler comprises mixing the minced dermalplugs with a carrier.

The carrier includes a fluid.

The carrier includes a gel.

The carrier includes hyaluronic acid.

The carrier includes hydrogel.

The carrier includes saline.

The carrier includes a bioactive agent.

The bioactive agent comprises a dermal growth factor.

The method includes centrifuging the injectable filler.

The injecting comprises injecting from a syringe.

The injecting is performed concurrently to the removing.

The injecting is performed during a same procedure as the removing.

The donor site comprises a field within a larger operative site.

The identifying the donor site comprises applying a template to anoperative site within the donor site.

The template is configured for marking the operative site.

The template includes at least one of perforations and peripheralnotches.

The perforations are configured to indicate at least one density for theplurality of dermal plugs.

The peripheral notches are configured to orient a subsequent applicationof the template.

The marking comprises marking the operative site through theperforations with at least one of ink and dye.

The marking comprises direct fractional marking resection through theperforations.

The method includes, following the harvesting, applying at least onebandage at the donor site.

The at least one bandage applies force to close the target site.

The at least one bandage applies directional force to control adirection of the closure at the target site.

The injecting comprises generating a pocket at the recipient site forthe injectable filler.

The method includes placing the injectable filler into the pocket.

The injecting comprises advancing the needle and injecting theinjectable filler.

The injecting comprises generating the pocket by advancing at least oneof a needle and an injection cannula into a region adjacent therecipient site.

The injecting comprises retracting the needle from the pocket whileinjecting the injectable filler.

The recipient site includes an aesthetic deformity.

The recipient site includes at least one of a furrow, a wrinkle, and afold.

The recipient site includes a vermillion cutaneous junction of an upperlip.

The recipient site includes at least one of a scar and a depressed scar.

The recipient site includes at least one of a contour deformity, a softtissue contour deformity, and a post traumatic depressed contourdeformity.

The recipient site includes at least one site adjacent at least one of aurethra and a bladder.

The recipient site includes at least one site adjacent an esophagealsphincter. The recipient site includes at least one site adjacent avocal cord.

Embodiments include a method comprising removing a portion of theepidermis within a donor site on a subject. The method includesharvesting a plurality of dermal plugs within the donor site. The methodincludes forming an injectable filler by mincing the dermal plugs. Themethod includes configuring the injectable filler for injecting into arecipient site on the subject. The recipient site is different from thedonor site.

Embodiments include a method comprising: removing a portion of theepidermis within a donor site on a subject; harvesting a plurality ofdermal plugs within the donor site; forming an injectable filler bymincing the dermal plugs; and configuring the injectable filler forinjecting into a recipient site on the subject, wherein the recipientsite is different from the donor site.

Embodiments include a method comprising excising skin from a donor siteon a subject. The method includes removing a portion of the epidermisfrom the excised skin. The method includes isolating a dermal layer ofthe excised skin by removing subcutaneous tissue. The method includesforming an injectable filler by mincing the dermal layer. The methodincludes injecting the injectable filler into a recipient site on thesubject. The recipient site is different from the donor site.

Embodiments include a method comprising: excising skin from a donor siteon a subject; removing a portion of the epidermis from the excised skin;isolating a dermal layer of the excised skin by removing subcutaneoustissue; forming an injectable filler by mincing the dermal layer; andinjecting the injectable filler into a recipient site on the subject,wherein the recipient site is different from the donor site.

Embodiments include a composition comprising a plurality of dermal plugsharvested from tissue of a subject at a donor site. The dermal plugs areminced. The composition includes a carrier including at least one of afluid and a gel. The carrier is mixed with the minced dermal plugs toform an injectable filler. The injectable filler is configured forinjection into the subject.

Embodiments include a composition comprising: a plurality of dermalplugs harvested from tissue of a subject at a donor site, wherein thedermal plugs are minced; and a carrier including at least one of a fluidand a gel, wherein the carrier is mixed with the minced dermal plugs toform an injectable filler, wherein the injectable filler is configuredfor injection into the subject.

The injectable filler comprises a live autologous dermal matrix (LADMIX)injectable filler.

The injectable filler comprises live fibroblasts.

The plurality of dermal plugs is harvested from a plurality of donorsites.

The plurality of dermal plugs is harvested directly from the subject.

The plurality of dermal plugs is harvested from the tissue subsequent tothe tissue being removed from the subject.

The plurality of dermal plugs exclude the epidermis.

The epidermis is removed in at least one region of the donor site.

The epidermis is removed by delaminating the epidermis from dermis inthe at least one region.

The delaminating comprises blistering skin.

The delaminating comprises vibratory shearing.

The vibratory shearing comprises at least one of vacuum and heat.

The delaminating comprises superficial injection.

The superficial injection comprises at least one of saline andanesthetic.

The epidermis is removed by dermabrasion.

The plurality of dermal plugs is harvested by fractionally resecting atleast one dermal plug from at least one region of a donor site.

The plurality of dermal plugs is harvested by fractionally resecting atleast one dermal plug from each of a plurality of regions of the donorsite.

The plurality of dermal plugs is harvested via at least one fractionalresection application at the donor site.

The at least one fractional resection application includes a staggeredfractional resection application at the donor site.

The at least one fractional resection application comprises a firstfractional resection application and a second fractional resectionapplication.

The first fractional resection application comprises epidermis removal.

The second fractional resection application comprises fractionalresection through dermis.

The second fractional resection comprises a partial-thickness fractionalresection through the dermis.

The second fractional resection comprises a full-thickness fractionalresection through the dermis.

A fractional defect skin edge of the second fractional resectionapplication comprises additional clearance relative to the fractionaldefect skin edge of the first fractional resection application.

At least one scalpet is inserted into the at least one donor region and,when fully inserted, rotated.

A housing comprising a scalpet assembly is positioned at a donor site,wherein the scalpet assembly includes a scalpet array and at least oneguide plate, wherein the scalpet array includes a plurality of scalpets,wherein the at least one guide plate maintains a configuration of theplurality of scalpets.

At least one scalpet of the scalpet array comprises a cylindricalscalpet including a cutting surface on a distal end of the scalpet.

The scalpet array is deployed from the housing into tissue at the donorsite and the plurality of dermal plugs are generated at the donor site.

At least a set of the plurality of scalpets is rotated.

The plurality of dermal plugs is passively extruded through a pluralityof lumens of the plurality of scalpets.

The plurality of dermal plugs is captured by a vacuum at the donor site,wherein the vacuum comprises pressure relatively lower than ambient airpressure.

The scalpet array is retracted into the housing from the donor site.

The plurality of dermal plugs is captured using an adherent substrate.

The incised dermal plugs are transected using a cutting member.

A scalpet array is applied to a donor site, wherein the scalpet arraycomprises a plurality of scalpets positioned on an investing plate.

The plurality of dermal plugs is circumferentially incised at the donorsite via a load applied by the scalpet array at a subjacent skin surfacethat includes a donor site.

The load is applied with a dermatome.

The dermatome includes at least one of a flat dermatome and a drumdermatome.

The plurality of dermal plugs is extruded through the scalpet array,wherein the plurality of dermal plugs is captured on an adherentsubstrate.

The adherent substrate is coupled to the dermatome.

Bases of the plurality of dermal plugs extruded through the scalpetarray are transected.

Bases of the plurality of dermal plugs extruded through the scalpetarray are transected with a cutting member coupled to the drumdermatome.

The plurality of dermal plugs is collected in a collection chambercoupled to the scalpet array.

The collection chamber is configured for at least one of receiving theplurality of dermal plugs, collecting the plurality of dermal plugs,mincing the plurality of dermal plugs, mixing the plurality of dermalplugs with a carrier, and a loading chamber for loading a compositioncomprising the plurality of dermal plugs into at least one of a needleand an injection cannula.

The collection chamber includes at least one of a pressurized chamberand an unpressurized chamber.

The plurality of dermal plugs is minced in the collection chamber.

The plurality of dermal plugs is minced with a rotating blade.

The carrier is mixed with the minced dermal plugs in the collectionchamber.

At least one of a needle and an injection cannula is used for theinjection, wherein the collection chamber is configured as a loadingchamber for the at least one of the needle and the injection cannula.

The plurality of dermal plugs is minced with at least one blade.

The mincing comprises at least one of manual mincing and poweredmincing.

The mincing comprises at least one of rotary mincing, reciprocatingmincing, oscillating mincing, and compressive morselization.

The mincing excludes compressive mincing.

The carrier includes at least one of a fluid and a gel.

The carrier includes at least one of hyaluronic acid, hydrogel, andsaline.

The carrier includes a bioactive agent.

The bioactive agent comprises a dermal growth factor.

The injectable filler is centrifuged.

The injectable filler is injected from a syringe.

The injectable filler is injected during a same procedure as harvestingof the plurality of dermal plugs.

The donor site comprises a field within a larger operative site.

A template is applied to the donor site, wherein the plurality of dermalplugs is harvested at the donor site.

The donor site is marked using the template.

The template includes at least one of perforations and peripheralnotches.

The perforations indicate at least one density for the plurality ofdermal plugs.

The peripheral notches orient a subsequent application of the template.

The donor site is marked through the perforations with at least one ofink and dye.

The donor site is marked using direct fractional marking resectionthrough the perforations.

At least one bandage is applied at the donor site subsequent toharvesting of the plurality of dermal plugs.

A closure force is applied by the at least one bandage.

A directional force is applied by the at least one bandage to control adirection of the closure.

The injectable filler is configured to be injected into a recipient siteon the subject, wherein the recipient site is different from the donorsite.

A pocket is generated at the recipient site for receiving the injectablefiller.

The pocket is generated when at least one of a needle and an injectioncannula is advanced into a region adjacent the recipient site.

The injectable filler is injected into the pocket using the at least oneof the needle and the injection cannula.

The recipient site includes at least one of an aesthetic deformity, afurrow, a wrinkle, a fold, a vermillion cutaneous junction of an upperlip, a scar, a depressed scar, a contour deformity, a soft tissuecontour deformity, a post traumatic depressed contour deformity, atleast one site adjacent at least one of a urethra and a bladder, atleast one site adjacent an esophageal sphincter, and at least one siteadjacent a vocal cord.

Embodiments include a system comprising a handpiece configured toremovably couple to a proximal end of a housing. The handpiece includesa drive system. The system includes a scalpet assembly configured toremoveably couple to a distal end of the housing and the drive system.The scalpet assembly includes a scalpet array comprising a plurality ofscalpets configured for rotation using force delivered from the drivesystem. The scalpet array is configured to harvest a plurality of dermalplugs from a donor site via fractional resection. The system includes acollection chamber coupled to the housing and configured to collect theplurality of dermal plugs generated by the scalpet assembly. Thecollection chamber is further configured to house formation of aninjectable filler by mincing the dermal plugs, and mixing the dermalplugs with a carrier. The injectable filler is configured for injectioninto the subject.

Embodiments include a system comprising: a handpiece configured toremovably couple to a proximal end of a housing, wherein the handpieceincludes a drive system; a scalpet assembly configured to removeablycouple to a distal end of the housing and the drive system, wherein thescalpet assembly includes a scalpet array comprising a plurality ofscalpets configured for rotation using force delivered from the drivesystem, wherein the scalpet array is configured to harvest a pluralityof dermal plugs from a donor site via fractional resection; and acollection chamber coupled to the housing and configured to collect theplurality of dermal plugs generated by the scalpet assembly, wherein thecollection chamber is further configured to house formation of aninjectable filler by mincing the dermal plugs, and mixing the dermalplugs with a carrier, wherein the injectable filler is configured forinjection into the subject.

The injectable filler comprises a live autologous dermal matrix (LADMIX)injectable filler.

The injectable filler comprises live fibroblasts.

The carrier includes at least one of a fluid and a gel.

The carrier includes at least one of hyaluronic acid, hydrogel, andsaline.

The carrier includes a bioactive agent.

The bioactive agent comprises a dermal growth factor.

The housing includes a vacuum port configured for coupling to a vacuumsource, wherein the vacuum comprises pressure relatively lower thanambient air pressure, wherein the housing is configured to capture theplurality of dermal plugs using the vacuum.

The plurality of dermal plugs is collected in the collection chamber.

The collection chamber includes at least one of a pressurized chamberand an unpressurized chamber.

The system includes an end cap configured to removeably couple to thedistal end of the housing, wherein the end cap includes a fittingconfigured to couple to at least one of a medical instrument and a plug,wherein the end cap replaces the scalpet assembly subsequent tocollection of the plurality of dermal plugs.

The fitting includes a Luer taper fitting.

The system includes a mincing blade configured to removeably couple tothe drive system for rotation using force delivered from the drivesystem, wherein the mincing blade replaces the scalpet assemblysubsequent to collection of the plurality of dermal plugs.

The plurality of dermal plugs is minced in the collection chamber.

The mincing blade includes at least one blade.

The mincing blade includes a plurality of blades.

The mincing comprises at least one of rotary mincing, reciprocatingmincing, oscillating mincing, and compressive morselization.

The mincing excludes compressive mincing.

The collection chamber is configured to load a composition comprisingthe dermal plugs into at least one of a syringe and an injection cannulacoupled to the fitting.

The at least one of the syringe and the injection cannula is used forthe injection.

The injectable filler is injected during a same procedure as theharvesting of the plurality of dermal plugs.

The injectable filler is configured to be injected into a recipient siteon the subject, wherein the recipient site is different from the donorsite.

A pocket is generated at the recipient site for receiving the injectablefiller.

The pocket is generated when at least one of a needle and an injectioncannula is advanced into a region adjacent the recipient site.

The injectable filler is injected into the pocket using the at least oneof the needle and the injection cannula.

The recipient site includes at least one of an aesthetic deformity, afurrow, a wrinkle, a fold, a vermillion cutaneous junction of an upperlip, a scar, a depressed scar, a contour deformity, a soft tissuecontour deformity, a post traumatic depressed contour deformity, atleast one site adjacent at least one of a urethra and a bladder, atleast one site adjacent an esophageal sphincter, and at least one siteadjacent a vocal cord.

The scalpet array is deployed from the housing into tissue at the donorsite and the plurality of dermal plugs are generated at the donor site.

The plurality of dermal plugs is passively extruded through a pluralityof lumens of the plurality of scalpets.

The plurality of dermal plugs is harvested from a plurality of donorsites. The plurality of dermal plugs excludes the epidermis.

The epidermis is removed in at least one region of the donor site.

The epidermis is removed by delaminating the epidermis from dermis inthe at least one region.

The delaminating comprises blistering skin.

The delaminating comprises vibratory shearing.

The vibratory shearing comprises at least one of vacuum and heat.

The delaminating comprises superficial injection.

The superficial injection comprises at least one of saline andanesthetic.

The epidermis is removed by dermabrasion.

The plurality of dermal plugs is harvested by fractionally resecting atleast one dermal plug from at least one region of the donor site.

The plurality of dermal plugs is harvested by fractionally resecting atleast one dermal plug from each of a plurality of regions of the donorsite.

The plurality of dermal plugs is harvested via at least one fractionalresection application at the donor site.

The at least one fractional resection application includes a staggeredfractional resection application at the donor site.

The at least one fractional resection application comprises a firstfractional resection application and a second fractional resectionapplication.

The first fractional resection application comprises epidermis removal.

The second fractional resection application comprises fractionalresection through dermis.

The second fractional resection comprises a partial-thickness fractionalresection through the dermis.

The second fractional resection comprises a full-thickness fractionalresection through the dermis.

A fractional defect skin edge of the second fractional resectionapplication comprises additional clearance relative to the fractionaldefect skin edge of the first fractional resection application.

At least one scalpet is inserted into the donor site and, when fullyinserted, rotated.

The donor site comprises a field within a larger operative site.

The system includes a template configured for application to the donorsite.

The donor site is marked using the template.

The template includes at least one of perforations and peripheralnotches.

The perforations indicate at least one density for the plurality ofdermal plugs.

The peripheral notches orient a subsequent application of the template.

The donor site is marked through the perforations with at least one ofink and dye.

The donor site is marked using direct fractional marking resectionthrough the perforations.

The system includes at least one bandage configured for application atthe donor site subsequent to harvesting of the plurality of dermalplugs.

The at least one bandage is configured to apply a closure force.

The at least one bandage is configured to apply a directional force tocontrol a direction of the closure.

The drive system comprises a geared drive system.

The drive system comprises a frictional drive system configured togenerate frictional forces through a compressive component of at least aset of the plurality of scalpets, wherein the frictional forces areconfigured to rotate at least a set of the plurality of scalpets.

The drive system comprises a helical drive system.

The drive system comprises a slotted drive system comprising a drive rodconfigured to couple with a slotted component of the scalpet array,wherein the drive rod is configured for up and down movement relative tothe scalpet array.

The drive system comprises an oscillating drive system configured tooscillate at least one scalpet of the scalpet array.

The scalpet assembly is configured to transmit an axial force to thetarget site.

The axial force comprises at least one of a continuous axial force andan impact force.

At least one scalpet of the scalpet array comprises a cylindricalscalpet including a cutting surface on a distal end of the scalpet.

The cutting surface includes a sharpened edge.

The cutting surface includes a serrated edge.

The cutting surface includes at least one radius of curvature.

The system includes a vibration system coupled to the scalpet array.

The system includes an electromagnetic system coupled to the scalpetarray and configured to couple electromagnetic energy to the scalpetarray, wherein the electromagnetic energy includes at least one of radiofrequency (RF) energy, laser energy, and ultrasonic energy.

Unless the context clearly requires otherwise, throughout thedescription, the words “comprise,” “comprising,” and the like are to beconstrued in an inclusive sense as opposed to an exclusive or exhaustivesense; that is to say, in a sense of “including, but not limited to.”Words using the singular or plural number also include the plural orsingular number respectively. Additionally, the words “herein,”“hereunder,” “above,” “below,” and words of similar import, when used inthis application, refer to this application as a whole and not to anyparticular portions of this application. When the word “or” is used inreference to a list of two or more items, that word covers all of thefollowing interpretations of the word: any of the items in the list, allof the items in the list and any combination of the items in the list.

The above description of embodiments is not intended to be exhaustive orto limit the systems and methods to the precise forms disclosed. Whilespecific embodiments of, and examples for, the medical devices andmethods are described herein for illustrative purposes, variousequivalent modifications are possible within the scope of the systemsand methods, as those skilled in the relevant art will recognize. Theteachings of the medical devices and methods provided herein can beapplied to other systems and methods, not only for the systems andmethods described above.

The elements and acts of the various embodiments described above can becombined to provide further embodiments. These and other changes can bemade to the medical devices and methods in light of the above detaileddescription.

In general, in the following claims, the terms used should not beconstrued to limit the medical devices and methods and correspondingsystems and methods to the specific embodiments disclosed in thespecification and the claims, but should be construed to include allsystems that operate under the claims. Accordingly, the medical devicesand methods and corresponding systems and methods are not limited by thedisclosure, but instead the scope is to be determined entirely by theclaims.

While certain aspects of the medical devices and methods andcorresponding systems and methods are presented below in certain claimforms, the inventors contemplate the various aspects of the medicaldevices and methods and corresponding systems and methods in any numberof claim forms. Accordingly, the inventors reserve the right to addadditional claims after filing the application to pursue such additionalclaim forms for other aspects of the medical devices and methods andcorresponding systems and methods.

What is claimed is:
 1. A system, comprising: a housing, a handpiececonfigured to removably couple to a proximal end of the housing, whereinthe handpiece includes a drive system; a scalpet assembly configured toremoveably couple to a distal end of the housing and the drive system,wherein the scalpet assembly includes a scalpet array comprising aplurality of scalpets configured for rotation using force delivered fromthe drive system, wherein the scalpet array is configured to harvest aplurality of dermal plugs from a donor site via fractional resection;and a collection chamber in an interior region of the housing andconfigured to collect the plurality of dermal plugs generated by thescalpet assembly, wherein the collection chamber is further configuredto house mincing and mixing of the dermal plugs with a carrier; an endcap configured to removably couple to the distal end of the housing andreplace the scalpet assembly subsequent to collection of the pluralityof dermal plugs; and a mincing blade configured to removably couple tothe drive system and replace the scalpet assembly subsequent tocollection of the plurality of dermal plugs.
 2. The system of claim 1,wherein the collection chamber is configured to contain formation of aninjectable filler comprising a live autologous dermal matrix (LADMIX)injectable filler including the carrier.
 3. The system of claim 2,wherein the injectable filler comprises live fibroblasts.
 4. The systemof claim 2, wherein the end cap includes a fitting configured to coupleto at least one of a medical instrument and a plug.
 5. The system ofclaim 4, wherein the fitting includes a Luer taper fitting.
 6. Thesystem of claim 4, wherein the mincing blade is configured rotate inresponse to force delivered from the drive system.
 7. The system ofclaim 6, wherein the mincing blade includes at least one blade.
 8. Thesystem of claim 6, wherein the mincing blade includes a plurality ofblades.
 9. The system of claim 6, wherein the mincing comprises at leastone of rotary mincing, reciprocating mincing, oscillating mincing, andcompressive morselization.
 10. The system of claim 6, wherein themincing excludes compressive mincing.
 11. The system of claim 4, whereinthe collection chamber is configured to load a composition comprisingthe dermal plugs into at least one of a syringe and an injection cannulacoupled to the fitting.
 12. The system of claim 11, wherein the at leastone of the syringe and the injection cannula is used for the injection.13. The system of claim 12, wherein the injectable filler is injectedduring a same procedure as the harvesting of the plurality of dermalplugs.
 14. The system of claim 12, wherein the injectable filler isconfigured to be injected into a recipient site on the subject, whereinthe recipient site is different from the donor site.
 15. The system ofclaim 14, wherein a pocket is generated at the recipient site forreceiving the injectable filler.
 16. The system of claim 15, wherein thepocket is generated when at least one of a needle and an injectioncannula is advanced into a region adjacent the recipient site.
 17. Thesystem of claim 15, wherein the injectable filler is injected into thepocket using the at least one of the needle and the injection cannula.18. The system of claim 14, wherein the recipient site includes at leastone of an aesthetic deformity, a furrow, a wrinkle, a fold, a vermillioncutaneous junction of an upper lip, a scar, a depressed scar, a contourdeformity, a soft tissue contour deformity, a post traumatic depressedcontour deformity, at least one site adjacent at least one of a urethraand a bladder, at least one site adjacent an esophageal sphincter, andat least one site adjacent a vocal cord.
 19. The system of claim 1,wherein the carrier includes at least one of a fluid and a gel.
 20. Thesystem of claim 1, wherein the carrier includes at least one ofhyaluronic acid, hydrogel, and saline.
 21. The system of claim 1,wherein the carrier includes a bioactive agent.
 22. The system of claim21, wherein the bioactive agent comprises a dermal growth factor. 23.The system of claim 1, wherein the housing includes a vacuum portconfigured for coupling to a vacuum source, wherein the vacuum comprisespressure relatively lower than ambient air pressure, wherein the housingis configured to capture the plurality of dermal plugs using the vacuum.24. The system of claim 1, wherein the collection chamber includes atleast one of a pressurized chamber and an unpressurized chamber.
 25. Thesystem of claim 1, wherein the scalpet array is deployed from thehousing into tissue at the donor site and the plurality of dermal plugsare generated at the donor site.
 26. The system of claim 1, wherein theplurality of dermal plugs is passively extruded through a plurality oflumens of the plurality of scalpets.
 27. The system of claim 1, whereinthe plurality of dermal plugs is harvested from a plurality of donorsites.
 28. The system of claim 1, wherein the plurality of dermal plugsexcludes the epidermis.
 29. The system of claim 28, wherein theepidermis is removed in at least one region of the donor site.
 30. Thesystem of claim 29, wherein the epidermis is removed by delaminating theepidermis from dermis in the at least one region.
 31. The system ofclaim 30, wherein the delaminating comprises blistering skin.
 32. Thesystem of claim 30, wherein the delaminating comprises vibratoryshearing.
 33. The system of claim 32, wherein the vibratory shearingcomprises at least one of vacuum and heat.
 34. The system of claim 30,wherein the delaminating comprises superficial injection.
 35. The systemof claim 34, wherein the superficial injection comprises at least one ofsaline and anesthetic.
 36. The system of claim 28, wherein the epidermisis removed by dermabrasion.
 37. The system of claim 1, wherein theplurality of dermal plugs is harvested by fractionally resecting atleast one dermal plug from at least one region of the donor site. 38.The system of claim 37, wherein the plurality of dermal plugs isharvested by fractionally resecting at least one dermal plug from eachof a plurality of regions of the donor site.
 39. The system of claim 1,wherein the plurality of dermal plugs is harvested via at least onefractional resection application at the donor site.
 40. The system ofclaim 39, wherein the at least one fractional resection applicationincludes a staggered fractional resection application at the donor site.41. The system of claim 39, wherein the at least one fractionalresection application comprises a first fractional resection applicationand a second fractional resection application.
 42. The system of claim41, wherein the first fractional resection application comprisesepidermis removal.
 43. The system of claim 41, wherein the secondfractional resection application comprises fractional resection throughdermis.
 44. The system of claim 43, wherein the second fractionalresection comprises a partial-thickness fractional resection through thedermis.
 45. The system of claim 43, wherein the second fractionalresection comprises a full-thickness fractional resection through thedermis.
 46. The system of claim 43, wherein a fractional defect skinedge of the second fractional resection application comprises additionalclearance relative to the fractional defect skin edge of the firstfractional resection application.
 47. The system of claim 43, wherein atleast one scalpet is inserted into the donor site and, when fullyinserted, rotated.
 48. The system of claim 1, wherein the donor sitecomprises a field within a larger operative site.
 49. The system ofclaim 1, comprising a template configured for application to the donorsite.
 50. The system of claim 49, wherein the donor site is marked usingthe template.
 51. The system of claim 50, wherein the template includesat least one of perforations and peripheral notches.
 52. The system ofclaim 51, wherein the perforations indicate at least one density for theplurality of dermal plugs.
 53. The system of claim 51, wherein theperipheral notches orient a subsequent application of the template. 54.The system of claim 50, wherein the donor site is marked through theperforations with at least one of ink and dye.
 55. The system of claim50, wherein the donor site is marked using direct fractional markingresection through the perforations.
 56. The system of claim 1,comprising at least one bandage configured for application at the donorsite subsequent to harvesting of the plurality of dermal plugs.
 57. Thesystem of claim 56, wherein the at least one bandage is configured toapply a closure force.
 58. The system of claim 56, wherein the at leastone bandage is configured to apply a directional force to control adirection of the closure.
 59. The system of claim 1, wherein the drivesystem comprises a geared drive system.
 60. The system of claim 1,wherein the drive system comprises a frictional drive system configuredto generate frictional forces through a compressive component of atleast a set of the plurality of scalpets, wherein the frictional forcesare configured to rotate at least a set of the plurality of scalpets.61. The system of claim 1, wherein the drive system comprises a helicaldrive system.
 62. The system of claim 1, wherein the drive systemcomprises a slotted drive system comprising a drive rod configured tocouple with a slotted component of the scalpet array, wherein the driverod is configured for up and down movement relative to the scalpetarray.
 63. The system of claim 1, wherein the drive system comprises anoscillating drive system configured to oscillate at least one scalpet ofthe scalpet array.
 64. The system of claim 1, wherein the scalpetassembly is configured to transmit an axial force to the target site.65. The system of claim 64, wherein the axial force comprises at leastone of a continuous axial force and an impact force.
 66. The system ofclaim 1, wherein at least one scalpet of the scalpet array comprises acylindrical scalpet including a cutting surface on a distal end of thescalpet.
 67. The system of claim 66, wherein the cutting surfaceincludes a sharpened edge.
 68. The system of claim 66, wherein thecutting surface includes a serrated edge.
 69. The system of claim 66,wherein the cutting surface includes at least one radius of curvature.70. The system of claim 1, comprising a vibration system coupled to thescalpet array.
 71. The system of claim 1, comprising an electromagneticsystem coupled to the scalpet array and configured to coupleelectromagnetic energy to the scalpet array, wherein the electromagneticenergy includes at least one of radio frequency (RF) energy, laserenergy, and ultrasonic energy.